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临床试验/NCT00200473
NCT00200473已完成3 期

A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Study of the Effects of Nebivolol on Safety and Efficacy in Patients With Mild to Moderate Hypertension

Mylan Bertek Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2001年9月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
800
试验地点
2
主要终点
The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

研究概览

简要总结

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

详细描述

This study was a multi-center, multi-national, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

排除标准

  • Recent myocardial infarction or stroke
  • Secondary hypertension
  • Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
  • Pregnancy, nursing or women of childbearing age not using appropriate contraception

结局指标

主要结局

The change of the average sitting diastolic blood pressure (24 plus/or minus 2 hours post-previous morning's dose) taken at trough at the end of the treatment compared to baseline

次要结局

  • - The change of the average sitting, supine and standing systolic and diastolic blood pressure at trough and peak at end of treatment compared to baseline
  • - Response rate

研究者

申办方类型
Industry

研究点 (2)

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