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Registro globale iCaReMe (iCaReMe)

7 settembre 2026 aggiornato da: AstraZeneca

Registro multinazionale del mondo reale per determinare la gestione e la qualità delle cure dei pazienti con diabete di tipo 2, ipertensione, insufficienza cardiaca e/o malattie renali croniche

Fornire dati del mondo reale sulle caratteristiche del paziente, la gestione della malattia, l'utilizzo dell'assistenza sanitaria e gli esiti in pazienti con diabete di tipo 2, ipertensione, insufficienza cardiaca e/o malattie renali croniche

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Reclutamento

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Descrizione dettagliata

Il registro intende fornire dati del mondo reale sulla gestione dei pazienti e sulla qualità delle cure per i pazienti con T2DM, ipertensione, insufficienza termica e malattia renale cronica nella pratica clinica in molti paesi. Per colmare questa lacuna, viene istituito un registro volontario osservazionale per acquisire dati del mondo reale sulle caratteristiche dei pazienti, sulla gestione della malattia, sull'utilizzo dell'assistenza sanitaria e sugli esiti nei pazienti con diabete di tipo 2, ipertensione, insufficienza cardiaca e malattia renale cronica. Registro osservazionale multinazionale che utilizza un eCRF basato su cloud, per la raccolta di dati prospettici e retrospettivi, accessibile ai ricercatori e al comitato scientifico. Questo registro sarà aperto a tutti i medici che gestiscono T2DM, HTN, HF o CKD in tutto il mondo.

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Osservativo

Iscrizione (Stimato)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
35000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Contatto studio

Il nome e le informazioni di contatto della persona che può rispondere alle domande di iscrizione per uno studio clinico. Ogni sede in cui viene condotto lo studio può anche avere un contatto specifico, che potrebbe essere maggiormente in grado di rispondere a tali domande.

Luoghi di studio

  • Brasile
      • São Paulo, Brasile, 05403-000
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 05403-900
        • Reclutamento
        • Research Site
    • Ceará
      • Fortaleza, Ceará, Brasile, 60840-285
        • Reclutamento
        • Research Site
    • Espírito Santo (ES)
      • Colatina, Espírito Santo (ES), Brasile, 29707-035
        • Reclutamento
        • Research Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasile, 40730-220
        • Reclutamento
        • Research Site
    • Federal District
      • Brasília, Federal District, Brasile, 70673-623
        • Reclutamento
        • Research Site
    • Minas Gerais
      • Poços de Caldas, Minas Gerais, Brasile, 37706-106
        • Reclutamento
        • Research Site
    • Paraná
      • Campina Grande do Sul, Paraná, Brasile, 83430-000
        • Reclutamento
        • Research Site
      • Curitiba, Paraná, Brasile, 80230-020
        • Reclutamento
        • Research Site
    • Piauí (PI)
      • Teresina, Piauí (PI), Brasile, 64001-450
        • Reclutamento
        • Research Site
    • Rio Grande Do Sul (RS)
      • Santa Cruz do Sul, Rio Grande Do Sul (RS), Brasile, 96835-090
        • Reclutamento
        • Research Site
    • State of Goias
      • Goiânia, State of Goias, Brasile, 74453-200
        • Reclutamento
        • Research Site
    • State of Santa Catarina
      • Joinville, State of Santa Catarina, Brasile, 89204-248
        • Reclutamento
        • Research Site
    • São Paulo
      • Bragança Paulista, São Paulo, Brasile, 12916-542
        • Reclutamento
        • Research Site
      • São Caetano do Sul, São Paulo, Brasile, 09521-160
        • Reclutamento
        • Research Site
  • Chile
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500922
        • Reclutamento
        • Research Site
  • Costa Rica
      • San José, Costa Rica
        • Reclutamento
        • Research Site
  • Côte d'Ivoire
      • Abidjan, Côte d'Ivoire
        • Reclutamento
        • Research Site
  • Egitto
      • Alexandria, Egitto
        • Reclutamento
        • Research Site
      • Cairo, Egitto
        • Reclutamento
        • Research Site
      • Giza, Egitto
        • Reclutamento
        • Research Site
  • Emirati Arabi Uniti
      • Sharjah city, Emirati Arabi Uniti
        • Reclutamento
        • Research Site
  • Filippine
      • Bulacan, Filippine
        • Non ancora reclutamento
        • Research Site
      • Cebu City, Filippine
        • Reclutamento
        • Research Site
      • Iloilo City, Filippine
        • Non ancora reclutamento
        • Research Site
      • Laguna, Filippine
        • Non ancora reclutamento
        • Research Site
      • Mandaluyong, Filippine
        • Non ancora reclutamento
        • Research Site
      • Manila, Filippine
        • Non ancora reclutamento
        • Research Site
      • Mindoro, Filippine
        • Non ancora reclutamento
        • Research Site
      • Pampanga, Filippine
        • Non ancora reclutamento
        • Research Site
      • Quezon City, Filippine
        • Non ancora reclutamento
        • Research Site
      • Zamboanga City, Filippine
        • Non ancora reclutamento
        • Research Site
  • Georgia
      • Tbilisi, Georgia
        • Reclutamento
        • Research Site
  • Ghana
      • Kumasi, Ghana
        • Reclutamento
        • Research Site
  • Hong Kong
      • Wan Chai, Hong Kong
        • Reclutamento
        • Research Site
  • India
      • Ahmedabad, India
        • Reclutamento
        • Research Site
      • Kolkata, India, 700034
        • Reclutamento
        • Research Site
      • Mumbai, India, 400006
        • Reclutamento
        • Research Site
  • Iraq
      • Sulaymaniyah, Iraq, 46001
        • Reclutamento
        • Research Site
  • Kazakistan
      • Aktobe, Kazakistan, 30019
        • Reclutamento
        • Research Site
      • Almaty, Kazakistan, 50000
        • Reclutamento
        • Research Site
      • Almaty, Kazakistan, 50006
        • Reclutamento
        • Research Site
      • Almaty, Kazakistan, 50012
        • Reclutamento
        • Research Site
      • Almaty, Kazakistan, 50054
        • Reclutamento
        • Research Site
  • Kenya
      • Nairobi, Kenya, 14497
        • Reclutamento
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Reclutamento
        • Research Site
  • Messico
      • Iztapalapa, Messico
        • Reclutamento
        • Research Site
      • Mexico City, Messico, 06720
        • Reclutamento
        • Research Site
      • Mexico City, Messico
        • Reclutamento
        • Research Site
      • México, Messico, 04530
        • Reclutamento
        • Research Site
    • Guanajuato
      • León, Guanajuato, Messico, 37549
        • Reclutamento
        • Research Site
  • Nigeria
      • Enugu, Nigeria, 400001
        • Reclutamento
        • Research Site
      • Gwagwalada, Nigeria, 901002
        • Reclutamento
        • Research Site
      • Kano, Nigeria, 700233
        • Reclutamento
        • Research Site
  • Sud Africa
      • Florida, Sud Africa, 1794
        • Reclutamento
        • Research Site
      • Parow, Sud Africa, 7505
        • Reclutamento
        • Research Site
      • Umhlanga, Sud Africa, 4320
        • Reclutamento
        • Research Site
      • Umhlanga, Sud Africa, 4319
        • Reclutamento
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500209
        • Reclutamento
        • Research Site
      • Kaohsiung City, Taiwan, 81301
        • Reclutamento
        • Research Site
      • Niaosong, Taiwan, 83301
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 40447
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 40705
        • Reclutamento
        • Research Site
      • Taichung, Taiwan
        • Reclutamento
        • Research Site
      • Tainan, Taiwan, 704
        • Reclutamento
        • Research Site
      • Taipei, Taiwan
        • Reclutamento
        • Research Site
      • Taoyuan City, Taiwan, 33305
        • Reclutamento
        • Research Site
  • Ucraina
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ucraina, 49005
        • Reclutamento
        • Research Site
    • Kharkiv Oblast
      • Kharkiv, Kharkiv Oblast, Ucraina, 61039
        • Reclutamento
        • Research Site
      • Kharkiv, Kharkiv Oblast, Ucraina
        • Reclutamento
        • Research Site
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ucraina, 3039
        • Reclutamento
        • Research Site
      • Kyiv, Kyiv Oblast, Ucraina, 4050
        • Reclutamento
        • Research Site
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ucraina, 21000
        • Reclutamento
        • Research Site
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ucraina, 43024
        • Reclutamento
        • Research Site
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ucraina, 88000
        • Reclutamento
        • Research Site
    • Zaporizhzhia Oblast
      • Zaporizhzhya, Zaporizhzhia Oblast, Ucraina, 69035
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adulti con diabete di tipo 2, ipertensione, insufficienza cardiaca e/o malattia renale cronica

Descrizione

Criterio di inclusione:

  1. Avere 18 anni o più
  2. Diabete di tipo 2, ipertensione, insufficienza cardiaca e/o malattia renale cronica
  3. Fornire il consenso informato scritto per partecipare al registro

Criteri di esclusione:

  1. Avere una comorbilità pericolosa per la vita con un'aspettativa di vita inferiore a 1 anno
  2. Partecipazione a uno studio interventistico che richiede il consenso informato

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Altro
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte

Gruppo / Coorte

Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
T2DM Cohort
Patients with T2DM as enrollment motif or T2DM as comorbidity
HTN Cohort
Patients with HTN as enrollment motif or HTN as comorbidity
CKD Cohort
Patients with CKD as enrollment motif or CKD as comorbidity
HF Cohort
Patients with HF as enrollment motif or HF as comorbidity

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
1. Age of particpants
Lasso di tempo: At Baseline
Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
At Baseline
2. Percentage of Participants by Sex
Lasso di tempo: At baseline
Distribution of participants by sex (male/female) reported as counts and percentages.
At baseline
3. Percentage of Participants by Ethnicity
Lasso di tempo: At Baseline
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
At Baseline
4. Percentage of Participants by Education Level
Lasso di tempo: At Baseline
Distribution of participants by education level reported as counts and percentages for each education category.
At Baseline
5. Percentage of Participants by Marital Status
Lasso di tempo: At Baseline
Distribution of participants by marital status reported as counts and percentages for each marital status category.
At Baseline
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease
Lasso di tempo: At Baseline
Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
At Baseline
7.Percentage of Participants by Physical Activity Level
Lasso di tempo: At Baseline
Distribution of participants by physical activity level category reported as counts and percentages.
At Baseline
8. Percentage of Participants by Smoking Status
Lasso di tempo: At Baseline
Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
At Baseline
9. Percentage of Participants by Alcohol Consumption
Lasso di tempo: At Baseline
Distribution of participants by alcohol consumption category reported as counts and percentages.
At Baseline
10. Body Weight of Participants
Lasso di tempo: At Baseline
Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
At Baseline
11. Height of Participants
Lasso di tempo: At Baseline
Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
At Baseline
12. Body Mass Index (BMI) of Participants
Lasso di tempo: At Baseline
Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
At Baseline
13. Waist Circumference of Participants
Lasso di tempo: At Baseline
Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
At Baseline
14. Waist-to-Hip Ratio of Participants
Lasso di tempo: At Baseline
Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
At Baseline
15. Waist-to-Height Ratio of Participants
Lasso di tempo: At Baseline
Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
At Baseline
16. Percentage of Participants by Cardiac and Renal Functional Measurements Category
Lasso di tempo: At Baseline
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
At Baseline
17. Primary Disease Duration
Lasso di tempo: At Baseline
Duration of primary disease (T2DM, HTN, HF, or CKD) from initial diagnosis to enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
At Baseline
18. Percentage of Participants by Number and Types of Comorbidities
Lasso di tempo: At Baseline
Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
At Baseline
19. Percentage of Participants by NYHA Functional Class
Lasso di tempo: At Baseline
Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
At Baseline
20. Percentage of Participants by Heart Failure Phenotype
Lasso di tempo: At Baseline
Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
At Baseline
21. Percentage of Participants by Heart Failure Etiology
Lasso di tempo: At Baseline
Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
At Baseline
22. Percentage of Participants by CKD Etiology
Lasso di tempo: At Baseline
Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
At Baseline
23. Percentage of Participants by Hypertension Stage
Lasso di tempo: At Baseline
Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
At Baseline
24. Percentage of Participants by Secondary Hypertension Etiology
Lasso di tempo: At Baseline
Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
At Baseline
25. Office Systolic and Diastolic Blood Pressure
Lasso di tempo: At Baseline
Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
At Baseline
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values
Lasso di tempo: At Baseline
Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
At Baseline
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
Lasso di tempo: At Baseline
Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
At Baseline
28. Blood HbA1c
Lasso di tempo: Average of 3 years
HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
Average of 3 years
29. Fasting Glucose
Lasso di tempo: Average of 3 years
Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
Average of 3 years
30. Lipid Profile Testing
Lasso di tempo: Average of 3 years
Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
Average of 3 years
31. Serum Creatinine
Lasso di tempo: Average of 3 years
Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
Average of 3 years
32. Estimated Glomerular Filtration Rate (eGFR)
Lasso di tempo: Average of 3 years
Estimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².
Average of 3 years
33. Urine Albumin-to-Creatinine Ratio (UACR)
Lasso di tempo: Average of 3 years
Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
Average of 3 years
34. Serum Electrolyte Values
Lasso di tempo: Avergae of 3 years
Serum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.
Avergae of 3 years
35. Frequency of HbA1c Testing
Lasso di tempo: Average of 3 years
Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
36. Frequency of Fasting Glucose Testing
Lasso di tempo: Average of 3 years
Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
37. Frequency of Lipid Profile Testing
Lasso di tempo: Average of 3 years
Frequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
38. Frequency of Serum Creatinine Testing
Lasso di tempo: Average of 3 years
Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
39. Frequency of eGFR Assessment
Lasso di tempo: Average of 3 years
Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
Average of 3 years
40. Frequency of Urine Albumin-to-Creatinine Ratio Testing
Lasso di tempo: Average of 3 years
Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
Average of 3 years
41. Echocardiography
Lasso di tempo: Average of 3 years
Frequency of echocardiography abnormalities reported as counts and percentages
Average of 3 years
42. Electrocardiogram (ECG)
Lasso di tempo: Average of 3 years
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Average of 3 years
43. Participants Receiving Dietary Modification Counseling
Lasso di tempo: Average of 3 years
Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
Average of 3 years
44. Participants Enrolled in Exercise Programs
Lasso di tempo: Average of 3 years
Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
Average of 3 years
45. Participants Receiving Weight Management Interventions
Lasso di tempo: Average of 3 years
Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
Average of 3 years
46. Participants Receiving Smoking Cessation Counseling
Lasso di tempo: Average of 3 years
Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
Average of 3 years
47. Participants Receiving Alcohol Reduction Counseling
Lasso di tempo: Average of 3 years
Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
Average of 3 years
48. Percentage of Participants by Line of Treatment
Lasso di tempo: Average of 3 years
Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
Average of 3 years
49. Percentage of Participants by Drug Class
Lasso di tempo: Average of 3 years
Distribution of participants by drug class prescribed (e.g., SGLT2i, GLP-1RA, ACEi, ARBs, beta-blockers, MRAs, CCBs, diuretics, metformin, DPP-4i, sulfonylureas, insulin) reported as counts and percentages.
Average of 3 years
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
Lasso di tempo: Average of 3 years
Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
Average of 3 years
51. Percentage of Participants Receiving Dialysis
Lasso di tempo: Average of 3 years
Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
Average of 3 years
52. Percentage of Participants with Cardiac Device Implantation
Lasso di tempo: Average of 3 years
Percentage of participants with cardiac device implantation (pacemaker, implantable cardioverter-defibrillator [ICD], or cardiac resynchronization therapy [CRT]) reported as counts and percentages for each device type.
Average of 3 years
53. Mean Duration of Pharmacological Treatments
Lasso di tempo: Average of 3 years
Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
Average of 3 years
54. Drug Dose of Pharmacological Treatments
Lasso di tempo: Average of 3 years
Drug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.
Average of 3 years
55. Number of Primary Care Visits per Participant
Lasso di tempo: Average of 3 years
Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
Average of 3 years
56. Number of Tertiary Care Hospital Visits per Participant
Lasso di tempo: Average of 3 years
Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
Average of 3 years
57. Number of Specialist Care Visits per Participant
Lasso di tempo: Average of 3 years
Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
Average of 3 years
58.Number of Emergency Department Visits per Participant
Lasso di tempo: Average of 3 years
Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
Average of 3 years
59. All-Cause Hospitalizations
Lasso di tempo: Average of 3 years
All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
Average of 3 years
60. Disease-Specific Hospitalizations
Lasso di tempo: Average of 3 years
Disease-specific hospitalizations (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
Average of 3 years
61. All-Cause Emergency Department Visits
Lasso di tempo: Average of 3 years
All-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
Average of 3 years
62. Disease-Specific Emergency Department Visits
Lasso di tempo: Average of 3 years
Disease-specific emergency department visits (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
Average of 3 years
63. Length of Hospital Stay
Lasso di tempo: Average of 3 years
Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
Average of 3 years

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
Lasso di tempo: Average of 3 years
Hypoglycemic events defined as blood glucose <70 mg/dL (Level 1 - alert value) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Average of 3 years
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)
Lasso di tempo: Average of 3 years
Hypoglycemic events defined as blood glucose <54 mg/dL (Level 2 - clinically significant) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Average of 3 years
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)
Lasso di tempo: Average of 3 years
Severe hypoglycemic events requiring third-party assistance (Level 3) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.
Average of 3 years
4.Incidence of Diabetic Ketoacidosis (DKA) Episodes
Lasso di tempo: Average of 3 years
Diabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.
Average of 3 years
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)
Lasso di tempo: Average of 3 years
Percentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.
Average of 3 years
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)
Lasso di tempo: Average of 3 years
Percentage of participants with uncontrolled hypertension defined as blood pressure ≥140/90 mmHg or ≥130/80 mmHg (per applicable guideline threshold) reported as counts and percentages.
Average of 3 years
7. Incidence of Retinopathy
Lasso di tempo: Average of 3 years
Incidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.
Average of 3 years
8. Incidence of Nephropathy
Lasso di tempo: Average of 3 years
Incidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.
Average of 3 years
9. Incidence of Neuropathy
Lasso di tempo: Average of 3 years
Incidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.
Average of 3 years
10. Incidence of Myocardial Infarction (MI)
Lasso di tempo: Average of 3 years
Incidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
Average of 3 years
11. Incidence of Stroke
Lasso di tempo: Average of 3 years
Incidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
Average of 3 years
12. Incidence of Peripheral Arterial Disease (PAD)
Lasso di tempo: Average of 3 years
Incidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.
Average of 3 years
13. Incidence of Coronary Revascularization
Lasso di tempo: Average of 3 years
Incidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.
Average of 3 years
14. Incidence of New-Onset Heart Failure
Lasso di tempo: Average of 3 years
Incidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.
Average of 3 years
15. Incidence of New-Onset Chronic Kidney Disease
Lasso di tempo: Average of 3 years
Incidence of new-onset chronic kidney disease defined as eGFR <60 mL/min/1.73m² or urine albumin-to-creatinine ratio (UACR) ≥30 mg/g reported as counts, percentages of participants, and incidence per 100 person-years.
Average of 3 years
16. Percentage of Participants Developing Anemia
Lasso di tempo: Average of 3 years
Percentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.
Average of 3 years
17. Percentage of Participants Developing Hyperkalemia
Lasso di tempo: Average of 3 years
Percentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.
Average of 3 years
18. Percentage of Participants with Heart Failure Hospitalization
Lasso di tempo: Average of 3 years
Percentage of participants with at least one heart failure hospitalization reported as counts and percentages.
Average of 3 years
19. Percentage of Participants with eGFR Decline
Lasso di tempo: Average of 3 years
Percentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.
Average of 3 years
20. Percentage of Participants with RRT Initiation or ESRD Progression
Lasso di tempo: Average of 3 years
Percentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.
Average of 3 years
21. Incidence of Renal Replacement Therapy Initiation or ESRD Progression
Lasso di tempo: Average of 3 years
Incidence of renal replacement therapy (RRT) initiation or progression to end-stage renal disease (ESRD) reported as counts, percentages of participants, and rate per 100 person-years.
Average of 3 years
22. Incidence of All-Cause Mortality
Lasso di tempo: Average of 3 years
All-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.
Average of 3 years
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic Events
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and incidence of hypoglycemic events.
Average of 3 years
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DM
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled T2DM (HbA1c ≥7%).
Average of 3 years
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTN
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled HTN (BP ≥140/90 mmHg).
Average of 3 years
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure Worsening
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and heart failure worsening.
Average of 3 years
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD Progression
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and CKD Progression/RRT Initiation/ESRD Progression
Average of 3 years
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortality
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and All-cause mortality
Average of 3 years
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PAD
Lasso di tempo: Average of 3 years
Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and Myocardial Infarction/Stroke/PAD
Average of 3 years
31. Correlation Between Patient Characteristics and Treatment Choices for T2DM
Lasso di tempo: Average of 3 years
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for T2DM (line of treatment and drug class: metformin, SGLT2i, GLP-1RA, DPP-4i, sulfonylureas, insulin).
Average of 3 years
32. Correlation Between Patient Characteristics and Treatment Choices for HTN
Lasso di tempo: Average of 3 years
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HTN (line of treatment and drug class: ACEi, ARBs, CCBs, beta-blockers, diuretics).
Average of 3 years
33. Correlation Between Patient Characteristics and Treatment Choices for HF
Lasso di tempo: Average of 3 years
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HF (line of treatment and drug class: ACEi, ARBs, ARNI, beta-blockers, MRAs, SGLT2i).
Average of 3 years
34. Correlation Between Patient Characteristics and Treatment Choices for CKD
Lasso di tempo: Average of 3 years
Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for CKD (line of treatment and drug class: ACEi, ARBs, SGLT2i).
Average of 3 years
35. Percentage of Participants with Dyslipidemia by Category
Lasso di tempo: Average of 3 years
Distribution of participants with dyslipidemia by category reported as counts and percentages.
Average of 3 years
36. Percentage of Participants with Obesity by Category
Lasso di tempo: Average of 3 years
Distribution of participants with obesity by BMI category reported as counts and percentages.
Average of 3 years
37. Percentage of Participants Achieving LDL-C Target <100 mg/dL
Lasso di tempo: Average of 3 years
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL reported as counts and percentages.
Average of 3 years
38. Percentage of Participants Achieving LDL-C Target <70 mg/dL
Lasso di tempo: Average of 3 years
Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL reported as counts and percentages.
Average of 3 years
40. Percentage of Participants Achieving Weight Loss ≥5%
Lasso di tempo: Average of 3 years
Percentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.
Average of 3 years
41. Percentage of Participants Achieving Weight Loss ≥10%
Lasso di tempo: Average of 3 years
Percentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.
Average of 3 years
42. Percentage of Participants Achieving Weight Loss ≥15%
Lasso di tempo: Average of 3 years
Percentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.
Average of 3 years
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Lasso di tempo: Average of 3 years
Percentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.
Average of 3 years
44. Percentage of Participants Developing T2DM as an Obesity Complication
Lasso di tempo: Average of 3 years
Percentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.
Average of 3 years
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Incidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.
Average of 3 years
46. Lipid levels in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Total cholesterol, LDL-C, HDL-C, Triglyceride in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
Average of 3 years
47. Body Weight in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Body weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
Average of 3 years
48. BMI in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Body mass index (BMI) in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
Average of 3 years
49. Waist Circumference in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Waist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
Average of 3 years
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years through
Waist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
Average of 3 years through
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Frequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
Average of 3 years
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Frequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
Average of 3 years
53. Frequency of Obesity Complication Assessments
Lasso di tempo: Average of 3 years
Frequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.
Average of 3 years
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Percentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.
Average of 3 years
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
Lasso di tempo: Average of 3 years
Counts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
Average of 3 years
56. Percentage of Participants Undergoing Bariatric Surgery
Lasso di tempo: Average of 3 years
Percentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.
Average of 3 years
57. Mean Number of Visits for Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Number of visits for dyslipidemia and/or obesity management reported as counts and percentages of participants with at least one visit. Visits for dyslipidemia and/or obesity management reported as mean ± standard deviation (SD) and total visits.
Average of 3 years
58. Percentage of Participants Hospitalized for Dyslipidemia/Obesity
Lasso di tempo: Average of 3 years
Percentage of participants with at least one hospitalization related to dyslipidemia and/or obesity reported as counts and percentages. Hospitalizations for dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and total hospitalizations.
Average of 3 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
AstraZeneca

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Direttore dello studio: Hardik Vasnawala, MD, AstraZeneca
  • Direttore dello studio: Isidro Villanueva, MD, AstraZeneca
  • Direttore dello studio: Ahmed Hadaoui, PharmD, AstraZeneca

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
17 febbraio 2018

Completamento primario (Stimato)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
31 dicembre 2030

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
15 maggio 2018

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
29 maggio 2018

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
8 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
7 settembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • D1690R00044

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I ricercatori qualificati possono richiedere l'accesso a dati anonimizzati a livello di singolo paziente dal gruppo di società AstraZeneca sponsorizzate da studi clinici tramite il portale delle richieste. Tutte le richieste saranno valutate secondo l'impegno di divulgazione di AZ:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Sì, indica che AZ accetta richieste di IPD, ma ciò non significa che tutte le richieste saranno condivise.

Periodo di condivisione IPD

AstraZeneca soddisferà o supererà la disponibilità dei dati in base agli impegni presi ai principi di condivisione dei dati farmaceutici EFPIA. Per i dettagli delle nostre tempistiche, fare riferimento al nostro impegno di divulgazione su https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

Quando una richiesta è stata approvata, AstraZeneca fornirà l'accesso ai dati dei singoli pazienti non identificati in uno strumento sponsorizzato approvato. L'accordo di condivisione dei dati firmato (contratto non negoziabile per gli accessi ai dati) deve essere in vigore prima di accedere alle informazioni richieste. Inoltre, tutti gli utenti dovranno accettare i termini e le condizioni del SAS MSE per ottenere l'accesso. Per ulteriori dettagli, consultare le dichiarazioni di divulgazione su https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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