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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Nebivolol

• Registration Number: NCT00770861
• Lead Sponsor: Forest Laboratories

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Primary Completion: 2009-11
• Results First Submitted: 2010-11-09
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-21
• Last Update Submitted: 2010-12-21
• Results First Posted: 2011-01-26
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablets, oral administration
Nebivolol	Nebivolol	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Seated DBP at Week 8(LOCF).	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 Outcome Measures

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

Trial Locations

Locations (2)

Forest Investigative Site; 🇵🇷 Santurce, Puerto Rico

Forest Investigative Site FL2; 🇺🇸 Hialeah, Florida, United States