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Completed

NCT Number: NCT00770861

A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site, Ponce, Puerto Rico

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 80 years of age, self-identified as Hispanic or Latino ethnicity
  • 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

  • Secondary hypertension
  • Are taking three or more antihypertensive agents
  • Have uncontrolled or poorly controlled diabetes mellitus type I or type II
  • Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
  • Participation in any investigational study within 30 days of Screening (Visit 1).
  • Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Treatment and study plan

nebivolol

Drug

Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets , oral administration 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 (TM)

Placebo

Drug

Matching placebo tablets, oral administration

Primary outcomes

  1. Change From Baseline in Trough Seated DBP at Week 8(LOCF).

    Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

    The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.

Secondary outcomes

  1. Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).

    Time frame: From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)

    The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled, Dose-Titration Study of Nebivolol Monotherapy in Hispanic Patients With Stage 1 or Stage 2 Hypertension

Important dates

Study start
2008
Primary completion
2009
First posted
Oct 10, 2008
Registry last updated
Jan 26, 2011

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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