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临床试验/NCT00200460
NCT00200460已完成3 期

A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure 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 825 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
825
试验地点
2
主要终点
The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline

研究概览

简要总结

The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

详细描述

This was a multi-center, 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 followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical 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 treatment or discontinuation of current antihypertensive therapy
  • Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception

结局指标

主要结局

The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline

次要结局

  • - Sitting SBP
  • - Supine SBP and DBP
  • - Standing SBP and DBP
  • - Response rate
  • - Correlation between plasma levels

研究者

申办方类型
Industry

研究点 (2)

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