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

Phase 4

Completed

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

• Registration Number: NCT00785512
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-03
• Study First Posted: 2008-11-05
• Primary Completion: 2009-08
• Status Verified: 2010-08
• Results First Submitted: 2010-08-19
• Results First Submitted QC: 2010-08-19
• Last Update Submitted: 2010-08-19
• Results First Posted: 2010-09-15
• Last Update Posted: 2010-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Matching placebo tablets, oral administration
1	Nebivolol	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
Trough Sitting Diastolic Blood Pressure	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 Outcome Measures

Name	Time	Method
Trough Sitting Systolic Blood Pressure	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.

Trial Locations

Locations (1)

Forest Investigative Site; 🇺🇸 Dallas, Texas, United States