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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

2014年1月15日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

589

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

-

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
药品：Aliskiren
Aliskiren 300 mg once daily
其他名称：
  • Tekturna, rasilez
实验性的：Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
药品：Aliskiren
Aliskiren 300 mg once daily
其他名称：
  • Tekturna, rasilez

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：8 weeks
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年4月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2012年4月2日

首先提交符合 QC 标准的

2012年4月2日

首次发布 (估计)

2012年4月4日

研究记录更新

最后更新发布 (估计)

2014年1月22日

上次提交的符合 QC 标准的更新

2014年1月15日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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