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Completed

NCT Number: NCT00200434

A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

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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

Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.

Exclusion criteria

  • Recent myocardial infarction or stroke
  • Contraindications to beta-blocker therapy

Treatment and study plan

nebivolol

Drug

Primary outcomes

  1. The change from baseline to week 12 in the average sitting DBP at trough.

Secondary outcomes

  1. Change from baseline to week 2, 6, and 12 in the average sitting, supine, standing systolic and diastolic blood pressure and sitting HR.

Sponsors and collaborators

Lead sponsor

Mylan Bertek Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

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

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