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

April 30, 2019 updated by: Forest Laboratories

Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Forest Research Institute 014
    • California
      • Beverly Hills, California, United States, 90211
        • Forest Research Institute 028
      • Encinitas, California, United States, 92024
        • Forest Research Institute 054
      • Roseville, California, United States, 95661
        • Forest Research Institute 025
      • Tustin, California, United States, 92780
        • Forest Research Institute 013
      • Vista, California, United States, 92083
        • Forest Research Institute 053
      • Walnut Creek, California, United States, 94598
        • Forest Research Institute 052
      • Westlake Village, California, United States, 91361
        • Forest Research Institute 033
    • Florida
      • DeLand, Florida, United States, 32720
        • Forest Research Institute 010
      • Holly Hill, Florida, United States, 32117
        • Forest Research Institute 019
      • Hollywood, Florida, United States, 33023
        • Forest Research Institute 036
      • Pembroke Pines, Florida, United States, 33024
        • Forest Research Institute 007
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Forest Research Institute 009
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Forest Research Institute 006
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Forest Research Institute 027
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Forest Research Institute 050
      • Wilmington, North Carolina, United States, 28401
        • Forest Research Institute 039
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Forest Investigative Site 002
      • Greenville, South Carolina, United States, 29615
        • Forest Research Institute 032
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Forest Research Institute 008
    • Texas
      • Carrollton, Texas, United States, 75006
        • Forest Research Institute 003
      • San Antonio, Texas, United States, 78229
        • Forest Research Institute 012
      • Sugar Land, Texas, United States, 77479
        • Forest Research Institute 048
    • Utah
      • Bountiful, Utah, United States, 84010
        • Forest Research Institute 040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebivolol
Nebivolol 5 mg, 10 mg or 20 mg
Drug: Nebivolol
Nebivolol once daily, oral administration
Active Comparator: Metoprolol ER
Metoprolol ER 50 mg, 100 mg or 200 mg
Drug: Metoprolol ER
Metoprolol ER once daily, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Mylan Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2007

Primary Completion (Actual)

January 2, 2008

Study Completion (Actual)

January 2, 2008

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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