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

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metoprolol ER
Nebivolol
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Nebivolol, Beta blocker, Tolerability

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Research Institute 014
  • Forest Research Institute 028
  • Forest Research Institute 054
  • Forest Research Institute 025
  • Forest Research Institute 013
  • Forest Research Institute 053
  • Forest Research Institute 052
  • Forest Research Institute 033
  • Forest Research Institute 010
  • Forest Research Institute 019
  • Forest Research Institute 036
  • Forest Research Institute 007
  • Forest Research Institute 009
  • Forest Research Institute 006
  • Forest Research Institute 027
  • Forest Research Institute 050
  • Forest Research Institute 039
  • Forest Investigative Site 002
  • Forest Research Institute 032
  • Forest Research Institute 008
  • Forest Research Institute 003
  • Forest Research Institute 012
  • Forest Research Institute 048
  • Forest Research Institute 040

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebivolol

Metoprolol ER

Arm Description

Nebivolol 5 mg, 10 mg or 20 mg

Metoprolol ER 50 mg, 100 mg or 200 mg

Outcomes

Primary Outcome Measures

Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).

Secondary Outcome Measures

Peripheral Blood Pressure (BP)
Pulse Rate

Full Information

First Posted
October 19, 2007
Last Updated
April 30, 2019
Sponsor
Forest Laboratories
Collaborators
Mylan Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00547300
Brief Title
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension
Official Title
Tolerability of Nebivolol Compared With Metoprolol ER in Patients With Mild to Moderate Hypertension Taking Hydrochlorothiazide (HCTZ)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Study Start Date
October 31, 2007 (Actual)
Primary Completion Date
January 2, 2008 (Actual)
Study Completion Date
January 2, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Mylan Laboratories

4. Oversight

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Nebivolol, Beta blocker, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol
Arm Type
Experimental
Arm Description
Nebivolol 5 mg, 10 mg or 20 mg
Arm Title
Metoprolol ER
Arm Type
Active Comparator
Arm Description
Metoprolol ER 50 mg, 100 mg or 200 mg
Intervention Type
Drug
Intervention Name(s)
Metoprolol ER
Intervention Description
Metoprolol ER once daily, oral administration
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Intervention Description
Nebivolol once daily, oral administration
Primary Outcome Measure Information:
Title
Change From Baseline in the Patient Symptoms Questionnaire (PSQ) Derived Score
Description
The PSQ contained 44 possible symptoms rated from 0 (no discomfort) to 5 (extreme discomfort).
Time Frame
Measurements occured over a 14 week period, from Visit 2 (Week -2) to Visit 10 (Week 12)
Secondary Outcome Measure Information:
Title
Peripheral Blood Pressure (BP)
Time Frame
Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)
Title
Pulse Rate
Time Frame
Measurements occured over a 18 week period, from Visit 1 (Week -4) through Visit 11 (Week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Forest Research Institute 014
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Forest Research Institute 028
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Forest Research Institute 054
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Forest Research Institute 025
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Forest Research Institute 013
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Forest Research Institute 053
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Forest Research Institute 052
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Forest Research Institute 033
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Forest Research Institute 010
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Research Institute 019
City
Holly Hill
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Forest Research Institute 036
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Forest Research Institute 007
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Forest Research Institute 009
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Forest Research Institute 006
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Forest Research Institute 027
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Forest Research Institute 050
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Forest Research Institute 039
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Forest Investigative Site 002
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Forest Research Institute 032
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Research Institute 008
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Forest Research Institute 003
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Forest Research Institute 012
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Research Institute 048
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Forest Research Institute 040
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States

12. IPD Sharing Statement

Links:
URL
http://frx.com
Description
Related Info
URL
http://mylan.com
Description
Related Info

Learn more about this trial

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

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