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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