Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

Overview

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

Full Title of Study: “Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2, 2008

Detailed Description

This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Interventions

  • Drug: Metoprolol ER
    • Metoprolol ER once daily, oral administration
  • Drug: Nebivolol
    • Nebivolol once daily, oral administration

Arms, Groups and Cohorts

  • Experimental: Nebivolol
    • Nebivolol 5 mg, 10 mg or 20 mg
  • Active Comparator: Metoprolol ER
    • Metoprolol ER 50 mg, 100 mg or 200 mg

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
    • Time Frame: Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
    • The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

Secondary Measures

  • Peripheral Blood Pressure (BP)
    • Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
  • Pulse Rate
    • Time Frame: Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female, ambulatory outpatients – History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine – SBP of 135-155 mm Hg and/or DBP of >85 mm Hg at screening (Visit 1) – SBP of 140-165 mm Hg and DBP > 90 mmHg at randomization (Visit 3) Exclusion Criteria:

  • Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1) – Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease) – Coronary artery disease requiring treatment with a calcium channel blocker or nitrates – Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1) – History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1) – Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants – Diabetes mellitus, type I or II – Participation in a previous investigational study of nebivolol at any time – Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1) – History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Forest Laboratories
  • Collaborator
    • Mylan Laboratories
  • Provider of Information About this Clinical Study
    • Sponsor

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