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Completed

NCT Number: NCT00785512

A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male and female outpatients 18 to 79 years of age
  • Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
  • meet criteria for stage I or II hypertension
  • currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion criteria

  • type 1 or type 2 diabetes
  • secondary hypertension
  • evidence of other concurrent disease or conditions that might interfere with the conduct of the study
  • treatment with any investigational study drug within 30 days of Screening (Visit 1)
  • have a history of hypersensitivity to nebivolol or other β-blockers

Treatment and study plan

nebivolol

Drug

Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration

Other names: Bystolic® (nebivolol)

Placebo

Drug

Matching placebo tablets, oral administration

Primary outcomes

  1. Trough Sitting Diastolic Blood Pressure

    Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

    Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.

Secondary outcomes

  1. Trough Sitting Systolic Blood Pressure

    Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

    Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy

Important dates

Study start
2008
Primary completion
2009
First posted
Nov 5, 2008
Registry last updated
Sep 15, 2010

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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