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A Study of the Safety and Efficacy of Nebivolol in Hypertensive Patients

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Mylan

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: Nebivolol

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

A study to determine the safety, efficacy and superiority of nebivolol to placebo for the treatment of elevated blood pressure in patients with mild to moderate hypertension.

Full description

This study was a multi-center, multi-national, 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 and 2) randomization/double-blind treatment. Patients had 7 scheduled clinic visits during the study.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline

Exclusion criteria

  • Recent myocardial infarction or stroke
  • Secondary hypertension
  • Contraindications to beta-blocker therapy or discontinuation of prior antihypertensive agents
  • Pregnancy, nursing or women of childbearing age not using appropriate contraception

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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