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8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 Hypertension (VANTAGE)

2011年3月31日 更新者：Novartis

An 8-week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Efficacy and Safety of Valsartan Administered in Combination With Aliskiren (160/150 mg, 320/300 mg) Versus Valsartan Alone (160 mg, 320 mg) in Patients With Stage 2 Hypertension

To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.

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)

451

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

  • 美国
    • New Jersey
      • East Hanover、New Jersey、美国、07936
        • Sites in USA

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 who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
  • Men or women 18 years and older.
  • Patients with Stage 2 systolic hypertension; defined as having a MSSBP ≥160 mmHg and <180 mmHg at Visit 5 (randomization).

Exclusion Criteria:

  • Use of aliskiren or participation in a clinical trial that had aliskiren as treatment within 30 days of Visit 1.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
  • Severe hypertension (an office cuff MSDBP ≥110 mmHg and/or MSSBP ≥180 mmHg).
  • Refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg).
  • Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
  • History or evidence of a secondary form of hypertension.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Valsartan/aliskiren
药品：Valsartan/aliskiren
Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
有源比较器：缬沙坦
药品：Valsartan
Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks

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 in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
大体时间：Baseline to Week 8
To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
Baseline to Week 8

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
大体时间：Baseline to Week 8
To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.
Baseline to Week 8
Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8
大体时间：At Week 8
To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
At Week 8
Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8
大体时间：At Week 8
To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
At Week 8
Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8
大体时间：Baseline to Week 8
To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
Baseline to Week 8
Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
大体时间：Baseline to Week 8
To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.
Baseline to Week 8

其他结果措施

结果测量
措施说明
大体时间
Completers Analysis for Change From Baseline in MSSBP at Week 8
大体时间：Baseline to week 8
To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population - patients who completed the double-blind treatment period.
Baseline to week 8
Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8
大体时间：Baseline through week 8
To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)
Baseline through week 8
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).
大体时间：Baseline to week 8
To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.
Baseline to week 8
Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)
大体时间：Baseline to week 8
To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.
Baseline to week 8

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2009年1月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年7月1日

研究注册日期

首次提交

2008年12月16日

首先提交符合 QC 标准的

2008年12月16日

首次发布 (估计)

2008年12月17日

研究记录更新

最后更新发布 (估计)

2011年5月2日

上次提交的符合 QC 标准的更新

2011年3月31日

最后验证

2011年3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

  • CSPV100AUS01

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.

2 期高血压的临床试验

Valsartan/aliskiren的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Moldova

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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