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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 januari 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

589

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Läkemedel: Aliskiren
Aliskiren 300 mg once daily
Andra namn:
  • Tekturna, rasilez
Experimentell: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Läkemedel: Aliskiren
Aliskiren 300 mg once daily
Andra namn:
  • Tekturna, rasilez

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 8 weeks
8 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 november 2012

Avslutad studie (Faktisk)

1 november 2012

Studieregistreringsdatum

Först inskickad

2 april 2012

Först inskickad som uppfyllde QC-kriterierna

2 april 2012

Första postat (Uppskatta)

4 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

22 januari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 januari 2014

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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