A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy
Overview
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.
Full Title of Study: “A Prospective, Randomized, Double-Blind, Placebo Controlled Study of the Long-Term Efficacy of Nebivolol in Hypertensive Patients After Withdrawal of Therapy”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2009
Interventions
- Drug: 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
- Drug: Placebo
- Matching placebo tablets, oral administration
Arms, Groups and Cohorts
- Active Comparator: 1
- 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 Comparator: 2
- Matching placebo tablets, oral administration
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 79 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Forest Laboratories
- Provider of Information About this Clinical Study
- John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc
- Overall Official(s)
- Tatjana Lukic, MD, MSc, Study Director, Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
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