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临床试验/NCT00200421
NCT00200421已完成2 期

A Double-Blind, Randomized, Multi-Center, Active Comparator, Five Treatment Study of the Effects of Nebivolol Compared to Atenolol on Cardiovascular Hemodynamics and Exercise Capacity 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 110 人开始时间: 2002年5月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
110
试验地点
2
主要终点
The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.

研究概览

简要总结

The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.

详细描述

This was a pilot, phase II, double-blind, randomized, muticenter, active-comparator, five treatment parallel group dosing and mechanistic study. The study consisted of two phases: 1) screen/washout/single-blind placebo run-in and 2) randomization/treatment. There was a minimum of five scheduled study visits.

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 (DBP) 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 stopping prior antihypertensive therapy

结局指标

主要结局

The percent change in sub-maximal exercise duration by cycle ergometer at peak drug effect at end of treatment compared to baseline.

次要结局

  • The change in sub-maximal exercise duration at end of treatment compared to baseline.

研究者

申办方类型
Industry

研究点 (2)

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