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临床试验/NCT00200499
NCT00200499已完成3 期

A Multi-Center, Parallel Group Extension Study to Determine the Safety and Efficacy of Long-Term Nebivolol Exposure in Patients With Mild to Moderate Hypertension

Mylan Bertek Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 845 人开始时间: 2002年3月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
845
试验地点
1
主要终点
The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.

研究概览

简要总结

The study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. This was an extension of the Phase III dose ranging studies NEB 202, 302 and 305. Nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

详细描述

This was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmHg and less then or equal to 109 mmHg when untreated, based on entry into NEB 202, NEB 302 or NEB 305). Patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. After successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. Patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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
否

入选标准

  • •To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB
  • •To enter the 4-week follow-up phase, patients must have completed NEB-306 (extension phase) and received only nebivolol monotherapy treatment during NEB 306.

排除标准

  • •Secondary hypertension
  • •myocardial infarction or stroke
  • •contraindications to beta-blocker therapy

结局指标

主要结局

The change in average sitting diastolic blood pressure measured at trough drug plasma level at the end of the extension phase compared to baseline of NEB 202, NEB 302 or NEB 305.

次要结局

  • Change in the average
  • - sitting systolic blood pressure
  • - supine and standing systolic and diastolic blood pressure
  • - response rate of treatment groups
  • - AEs
  • - ECGs
  • - laboratory parameters
  • - heart rate

研究者

申办方类型
Industry

研究点 (1)

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