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

Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770861
• Other study ID #: NEB-MD-16
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: December 21, 2010
• Start date: September 2008

Study information

• Verified date: December 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-blockers, or any contraindication to ß-blocker use

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• 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
• Placebo
Matching placebo tablets, oral administration

Locations

Country	Name	City	State
Puerto Rico	Forest Investigative Site	Ponce
Puerto Rico	Forest Investigative Site	Salinas
Puerto Rico	Forest Investigative Site	Santurce
United States	Forest Investigative Site	Atlanta	Georgia
United States	Forest Investigative Site	Atlanta	Georgia
United States	Forest Investigative Site	Bronx	New York
United States	Forest Investigative Site	Buena Park	California
United States	Forest Investigative Site	Carrollton	Texas
United States	Forest Investigative Site	Chino	California
United States	Forest Investigative Site	Coral Gables	Florida
United States	Forest Investigative Site	Corpus Christi	Texas
United States	Forest Investigative Site	Dallas	Texas
United States	Forest Investigative Site	El Paso	Texas
United States	Forest Investigative Site	Hialeah	Florida
United States	Forest Investigative Site	Hialeah	Florida
United States	Forest Investigative Site FL2	Hialeah	Florida
United States	Forest Investigative Site	Kissimmee	Florida
United States	Forest Investigative Site	Long Beach	California
United States	Forest Investigative Site	Los Angeles	California
United States	Forest Investigative Site	Miami	Florida
United States	Forest Investigative Site	Miami	Florida
United States	Forest Investigative Site	Miami	Florida
United States	Forest Investigative Site	National City	California
United States	Forest Investigative Site	New Windsor	New York
United States	Forest Investigative Site	Pembroke Pines	Florida
United States	Forest Investigative Site	Pembroke Pines	Florida
United States	Forest Investigative Site	San Antonio	Texas
United States	Forest Investigative Site	San Antonio	Texas
United States	Forest Investigative Site	San Bernardino	California
United States	Forest Investigative Site	Temecula	California
United States	Forest Investigative Site	Tustin	California
United States	Forest Investigative Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough Seated DBP at Week 8(LOCF).	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.	From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)	No
Secondary	Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).	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.	From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)	No