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Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

26 maggio 2016 aggiornato da: Teva Branded Pharmaceutical Products R&D, Inc.

A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

511

Fase

  • Fase 3

Contatti e Sedi

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

Luoghi di studio

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti
        • Investigational Site 861
      • Homewood, Alabama, Stati Uniti
        • Investigational Site 842
      • Jasper, Alabama, Stati Uniti
        • Investigational Site 887
    • Arizona
      • Tucson, Arizona, Stati Uniti
        • Investigational Site 809
      • Tucson, Arizona, Stati Uniti
        • Investigational Site 892
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti
        • Investigational Site 846
    • California
      • Anaheim, California, Stati Uniti
        • Investigational Site 828
      • Fresno, California, Stati Uniti
        • Investigational Site 900
      • Huntington Beach, California, Stati Uniti
        • Investigational Site 862
      • Los Angeles, California, Stati Uniti
        • Investigational Site 852
      • Los Angeles, California, Stati Uniti
        • Investigational Site 909
      • Newport Beach, California, Stati Uniti
        • Investigational Site 864
      • Rancho Mirage, California, Stati Uniti
        • Investigational Site 812
      • Riverside, California, Stati Uniti
        • Investigational Site 808
      • Sacramento, California, Stati Uniti
        • Investigational Site 804
    • Colorado
      • Centennial, Colorado, Stati Uniti
        • Investigational Site 837
      • Denver, Colorado, Stati Uniti
        • Investigational Site 851
      • Wheat Ridge, Colorado, Stati Uniti
        • Investigational Site 832
    • Florida
      • Jacksonville, Florida, Stati Uniti
        • Investigational Site 855
      • Miami, Florida, Stati Uniti
        • Investigational Site 865
      • Miami, Florida, Stati Uniti
        • Investigational Site 881
    • Georgia
      • Albany, Georgia, Stati Uniti
        • Investigational Site 805
      • Stockbridge, Georgia, Stati Uniti
        • Investigational Site 870
    • Illinois
      • Chicago, Illinois, Stati Uniti
        • Investigational Site 816
      • Shiloh, Illinois, Stati Uniti
        • Investigational Site 824
    • Indiana
      • Evansville, Indiana, Stati Uniti
        • Investigational Site 883
      • Fort Wayne, Indiana, Stati Uniti
        • Investigational Site 878
    • Kansas
      • Lenexa, Kansas, Stati Uniti
        • Investigational Site 820
    • Kentucky
      • Owensboro, Kentucky, Stati Uniti
        • Investigational Site 873
    • Louisiana
      • Lafayette, Louisiana, Stati Uniti
        • Investigational Site 801
      • Mandeville, Louisiana, Stati Uniti
        • Investigational Site 877
    • Maryland
      • White Marsh, Maryland, Stati Uniti
        • Investigational Site 875
    • Massachusetts
      • Fall River, Massachusetts, Stati Uniti
        • Investigational Site 871
      • North Dartmouth, Massachusetts, Stati Uniti
        • Investigational Site 834
    • Michigan
      • Troy, Michigan, Stati Uniti
        • Investigational Site 889
    • Missouri
      • Rolla, Missouri, Stati Uniti
        • Investigational Site 838
      • St. Louis, Missouri, Stati Uniti
        • Investigational Site 818
      • St. Louis, Missouri, Stati Uniti
        • Investigational Site 841
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti
        • Investigational Site 857
    • New York
      • Newburgh, New York, Stati Uniti
        • Investigational Site 819
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti
        • Investigational Site 844
    • Ohio
      • Middleburg Heights, Ohio, Stati Uniti
        • Investigational Site 845
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti
        • Investigational Site 810
    • Oregon
      • Ashland, Oregon, Stati Uniti
        • Investigational Site 859
      • Portland, Oregon, Stati Uniti
        • Investigational Site 859
    • Pennsylvania
      • Jenkintown, Pennsylvania, Stati Uniti
        • Investigational Site 854
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
        • Investigational Site 843
    • South Carolina
      • Florence, South Carolina, Stati Uniti
        • Investigational Site 802
      • Orangeburg, South Carolina, Stati Uniti
        • Investigational Site 814
      • Spartanburg, South Carolina, Stati Uniti
        • Investigational Site 821
      • Spartanburg, South Carolina, Stati Uniti
        • Investigational Site 829
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti
        • Investigational Site 850
      • Nashville, Tennessee, Stati Uniti
        • Investigational Site 803
    • Texas
      • Dallas, Texas, Stati Uniti
        • Investigational Site 880
      • Dickinson, Texas, Stati Uniti
        • Investigational Site 858
      • Live Oak, Texas, Stati Uniti
        • Investigational Site 869
      • Plano, Texas, Stati Uniti
        • Investigational Site 879
    • Utah
      • Salt Lake City, Utah, Stati Uniti
        • Investigational Site 847
      • West Jordan, Utah, Stati Uniti
        • Investigational Site 876
    • Virginia
      • Fairfax, Virginia, Stati Uniti
        • Investigational Site 840
      • Richmond, Virginia, Stati Uniti
        • Investigational Site 836
    • Washington
      • Seattle, Washington, Stati Uniti
        • Investigational Site 867
      • Spokane, Washington, Stati Uniti
        • Investigational Site 833
      • Vancouver, Washington, Stati Uniti
        • Investigational Site 904
    • Wisconsin
      • Greenfield, Wisconsin, Stati Uniti
        • Investigational Site 806
      • LaCrosse, Wisconsin, Stati Uniti
        • Investigational Site 823

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

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion criteria:

Patients are included in the study if all of the following criteria are met:

  • The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.
  • The patient has an ACQ score of at least 1.5.
  • At screening, the patient has airway reversibility of at least 12% to beta-agonist administration.
  • The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening and continue without dosage changes throughout study.
  • Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test at screening (serum) and baseline (urine).
  • Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
  • Written informed consent is obtained.
  • The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
  • The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
  • The patient has known hypereosinophilic syndrome (HES).
  • The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
  • The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
  • The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
  • The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
  • The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease).
  • The patient has participated in any investigative drug or device study within 30 days prior to screening.
  • The patient has participated in any investigative biologics study within 90 days prior to screening.
  • The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
  • The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency).
  • The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
  • The patient has presence of or suspected parasitic infestation/infection.
  • Patients may not have received any live attenuated vaccine within the 12-week period before study entry.

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

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo intravenous injection every 4 weeks for a total of 4 doses.
Droga: Placebo
Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
Sperimentale: Reslizumab 3.0 mg/kg
Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
Droga: Reslizumab
Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
Altri nomi:
  • Cinquillo
  • anticorpo monoclonale umanizzato
  • CEP-38072

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set
Lasso di tempo: Baseline (Day 1), Week 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group.
Baseline (Day 1), Week 16

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.

During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect.
Baseline (Day 1), Weeks 4, 8, 12, 16
Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16

The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.

During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect.
Baseline (Day 1), Weeks 4, 8, 12, 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation
Lasso di tempo: Baseline (Day 1), Week 16

FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.

As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline).
Baseline (Day 1), Week 16
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, and 16
FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, and 16
The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, and 16
The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, and 16
The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12, and 16
Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16
Lasso di tempo: Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16
SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.
Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16
Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)
Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.
Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)
Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16
Lasso di tempo: Baseline (Day 1), Weeks 4, 8, 12 and 16
The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.
Baseline (Day 1), Weeks 4, 8, 12 and 16
Participants With Treatment-Emergent Adverse Events
Lasso di tempo: Day 1 to Week 28
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Day 1 to Week 28
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
Lasso di tempo: Week 4 to Week 16

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.

Significance criteria:

  • Blood urea nitrogen: >=10.71 mmol/L
  • Creatinine: >=177 μmol/L
  • Uric acid: M>=625, F>=506 μmol/L
  • Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
  • Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
  • GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.
  • Total bilirubin: >=34.2 μmol/L
  • Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.
  • White blood cells: <=3.0 or >20 10^9/L
  • Hemoglobin: M<=115, F<=95 g/dL
  • Hematocrit: M<0.37, F<0.32 L/L
  • Platelets: <=75 10^9/L
  • Absolute neutrophil count: <=1.0 10^9/L
  • Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline
Week 4 to Week 16
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
Lasso di tempo: Week 4 to Week 28

Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.

Significance criteria

  • Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)
  • Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg
  • Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg
  • Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg
  • Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg
  • Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°
  • Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius
Week 4 to Week 28
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities
Lasso di tempo: Week 16 or endpoint
Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.
Week 16 or endpoint
Participants With a Positive Anti-Reslizumab Antibody Status During Study
Lasso di tempo: Screening (Week -3), Weeks 8 and 16

Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).

Endpoint =week 16 or early withdrawal.

Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point.
Screening (Week -3), Weeks 8 and 16

Collaboratori e investigatori

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

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigatori

  • Direttore dello studio: Global Respiratory Clinical Research, M.D., Sponsor's Medical Expert

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

1 febbraio 2012

Completamento primario (Effettivo)

1 agosto 2013

Completamento dello studio (Effettivo)

1 agosto 2013

Date di iscrizione allo studio

Primo inviato

3 gennaio 2012

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2012

Primo Inserito (Stima)

12 gennaio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

27 giugno 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C38072/3084

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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