Skip to main content
OpenTrials
Completed

NCT Number: NCT00200499

A Study of the Safety and Efficacy of Long-Term Nebivolol Use in Hypertensive Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mylan Pharmaceuticals Inc.

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To enter the long-term treatment phase, patients must have successfully completed NEB 202, NEB 302, or NEB 305. 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.

Exclusion criteria

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

Treatment and study plan

nebivolol

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in the average

  2. - sitting systolic blood pressure

  3. - supine and standing systolic and diastolic blood pressure

  4. - response rate of treatment groups

  5. - AEs

  6. - ECGs

  7. - laboratory parameters

  8. - heart rate

Sponsors and collaborators

Lead sponsor

Mylan Bertek Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Sep 20, 2005
Registry last updated
Dec 16, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.