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8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

15 gennaio 2014 aggiornato da: Novartis Pharmaceuticals

An 8-week Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Oral Aliskiren 300 mg Once Daily Under Light Meal Versus Fasted Condition in Patients With Hypertension

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

589

Fase

  • Fase 4

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

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Novartis Investigative Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Novartis Investigative Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Novartis Investigative Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novartis Investigative Site
      • Sainte-Foy, Quebec, Canada, G1W 4R4
        • Novartis Investigative Site
  • Italia
    • IS
      • Pozzilli, IS, Italia, 86077
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italia, 27100
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italia, 07100
        • Novartis Investigative Site
  • Porto Rico
      • Carolina, Porto Rico, 00983
        • Novartis Investigative Site
      • Cidra, Porto Rico, 00739
        • Novartis Investigative Site
      • Manati, Porto Rico, 00674
        • Novartis Investigative Site
  • Slovacchia
      • Bratislava, Slovacchia, 821 07
        • Novartis Investigative Site
      • Martin, Slovacchia, 036 01
        • Novartis Investigative Site
      • Presov, Slovacchia, 080 01
        • Novartis Investigative Site
      • Sala, Slovacchia, 927 03
        • Novartis Investigative Site
      • Zvolen, Slovacchia, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Kosice, Slovak Republic, Slovacchia, 040 11
        • Novartis Investigative Site
      • Svidnik, Slovak Republic, Slovacchia, 08901
        • Novartis Investigative Site
    • Slovak republic
      • Banská Bystrica, Slovak republic, Slovacchia, 97405
        • Novartis Investigative Site
      • Bratislava, Slovak republic, Slovacchia, 83299
        • Novartis Investigative Site
      • Kosice, Slovak republic, Slovacchia, 04001
        • Novartis Investigative Site
      • Nitra, Slovak republic, Slovacchia, 95201
        • Novartis Investigative Site
      • Rimavska Sobota, Slovak republic, Slovacchia, 97901
        • Novartis Investigative Site
      • Senec, Slovak republic, Slovacchia, 90301
        • Novartis Investigative Site
      • Snina, Slovak republic, Slovacchia, 09601
        • Novartis Investigative Site
      • Trnava, Slovak republic, Slovacchia, 91701
        • Novartis Investigative Site
  • Spagna
      • Madrid, Spagna, 28009
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spagna, 08905
        • Novartis Investigative Site
      • Centelles, Cataluña, Spagna, 08540
        • Novartis Investigative Site
      • Corbera de Llobregat, Cataluña, Spagna, 08757
        • Novartis Investigative Site
      • Hostalets de Balenya, Cataluña, Spagna, 08550
        • Novartis Investigative Site
      • Vic, Cataluña, Spagna, 08500
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alzira, Comunidad Valenciana, Spagna, 46600
        • Novartis Investigative Site
      • Quart de Poblet, Comunidad Valenciana, Spagna, 46930
        • Novartis Investigative Site
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90057
        • Novartis Investigative Site
      • Riverside, California, Stati Uniti, 92506
        • Novartis Investigative Site
      • Santa Monica, California, Stati Uniti, 90404
        • Novartis Investigative Site
      • Walnut Creek, California, Stati Uniti, 94598
        • Novartis Investigative Site
      • Westlake Village, California, Stati Uniti, 91361
        • Novartis Investigative Site
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33134
        • Novartis Investigative Site
      • Miami, Florida, Stati Uniti, 33169
        • Novartis Investigative Site
      • South Miami, Florida, Stati Uniti, 33143
        • Novartis Investigative Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60607
        • Novartis Investigative Site
      • Chicago, Illinois, Stati Uniti, 60610
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, Stati Uniti, 47712
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, Stati Uniti, 66606
        • Novartis Investigative Site
    • Louisiana
      • Opelousas, Louisiana, Stati Uniti, 70570
        • Novartis Investigative Site
    • Minnesota
      • Chaska, Minnesota, Stati Uniti, 55318
        • Novartis Investigative Site
      • Edina, Minnesota, Stati Uniti, 55435
        • Novartis Investigative Site
      • St. Paul, Minnesota, Stati Uniti, 55114
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39209
        • Novartis Investigative Site
      • Picayune, Mississippi, Stati Uniti, 39466
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, Stati Uniti, 63141
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28209
        • Novartis Investigative Site
      • Greensboro, North Carolina, Stati Uniti, 27401
        • Novartis Investigative Site
      • Greensboro, North Carolina, Stati Uniti, 27408
        • Novartis Investigative Site
      • Salisbury, North Carolina, Stati Uniti, 28144
        • Novartis Investigative Site
      • Shelby, North Carolina, Stati Uniti, 28152
        • Novartis Investigative Site
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45246
        • Novartis Investigative Site
      • Columbus, Ohio, Stati Uniti, 43213
        • Novartis Investigative Site
      • Lyndhurst, Ohio, Stati Uniti, 44124
        • Novartis Investigative Site
      • Marion, Ohio, Stati Uniti, 43302
        • Novartis Investigative Site
    • Oklahoma
      • Norman, Oklahoma, Stati Uniti, 73069
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Stati Uniti, 97404
        • Novartis Investigative Site
      • Oregon City, Oregon, Stati Uniti, 97045
        • Novartis Investigative Site
      • Portland, Oregon, Stati Uniti, 97239
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Stati Uniti, 37920
        • Novartis Investigative Site
    • Texas
      • Beaumont, Texas, Stati Uniti, 77702
        • Novartis Investigative Site
      • Houston, Texas, Stati Uniti, 77081
        • Novartis Investigative Site
      • Lake Jackson, Texas, Stati Uniti, 77566
        • Novartis Investigative Site
      • Pasadena, Texas, Stati Uniti, 77504
        • Novartis Investigative Site
    • Utah
      • Centerville, Utah, Stati Uniti, 84104
        • Novartis Investigative Site
    • Virginia
      • Arlington, Virginia, Stati Uniti, 22203
        • Novartis Investigative Site
      • Ettrick, Virginia, Stati Uniti, 23803
        • Novartis Investigative Site
      • Midlothian, Virginia, Stati Uniti, 23114
        • Novartis Investigative Site
    • Washington
      • Port Orchard, Washington, Stati Uniti, 98366
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative 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

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
  • Patients with an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit and the preceding visit
  • Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Exclusion Criteria:

  • Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
  • History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
  • Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%
  • Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

-

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Droga: Aliskiren
Aliskiren 300 mg once daily
Altri nomi:
  • Tekturna, rasilez
Sperimentale: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Droga: Aliskiren
Aliskiren 300 mg once daily
Altri nomi:
  • Tekturna, rasilez

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Lasso di tempo: Baseline, week 8
24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
Baseline, week 8

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Lasso di tempo: Baseline, week 8
24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
Baseline, week 8
Percentage of Patients Achieving Blood Pressure Control
Lasso di tempo: 8 weeks
Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg
8 weeks
Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
Lasso di tempo: Baseline, Week 8
Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.
Baseline, Week 8
Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction
Lasso di tempo: Baseline, Week 8
Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.
Baseline, Week 8
Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed
Lasso di tempo: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed
Lasso di tempo: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed
Lasso di tempo: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
Change From Baseline to Week 8 in Plasma Renin Activity (PRA)
Lasso di tempo: Baseline, Week 8
Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.
Baseline, Week 8
Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)
Lasso di tempo: Baseline, Week 8
Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.
Baseline, Week 8
Number of Patients With Adverse Events, Serious Adverse Events and Death
Lasso di tempo: 8 weeks
8 weeks

Collaboratori e investigatori

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

Sponsor

Novartis Pharmaceuticals

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 aprile 2012

Completamento primario (Effettivo)

1 novembre 2012

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

2 aprile 2012

Primo inviato che soddisfa i criteri di controllo qualità

2 aprile 2012

Primo Inserito (Stima)

4 aprile 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

22 gennaio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSPP100A2413
  • 2011-005297-36 (Numero EudraCT)

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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Condizioni

Malattie rare

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Sedi

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