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

NCT ID: NCT00547300

Last Updated: 2019-05-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-02

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nebivolol

Nebivolol 5 mg, 10 mg or 20 mg

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

Nebivolol once daily, oral administration

Metoprolol ER

Metoprolol ER 50 mg, 100 mg or 200 mg

Group Type ACTIVE_COMPARATOR

Metoprolol ER

Intervention Type DRUG

Metoprolol ER once daily, oral administration

Interventions

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Metoprolol ER

Metoprolol ER once daily, oral administration

Intervention Type DRUG

Nebivolol

Nebivolol once daily, oral administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mylan Laboratories

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Forest Research Institute 014

Birmingham, Alabama, United States

Site Status

Forest Research Institute 028

Beverly Hills, California, United States

Site Status

Forest Research Institute 054

Encinitas, California, United States

Site Status

Forest Research Institute 025

Roseville, California, United States

Site Status

Forest Research Institute 013

Tustin, California, United States

Site Status

Forest Research Institute 053

Vista, California, United States

Site Status

Forest Research Institute 052

Walnut Creek, California, United States

Site Status

Forest Research Institute 033

Westlake Village, California, United States

Site Status

Forest Research Institute 010

DeLand, Florida, United States

Site Status

Forest Research Institute 019

Holly Hill, Florida, United States

Site Status

Forest Research Institute 036

Hollywood, Florida, United States

Site Status

Forest Research Institute 007

Pembroke Pines, Florida, United States

Site Status

Forest Research Institute 009

Atlanta, Georgia, United States

Site Status

Forest Research Institute 006

Oxon Hill, Maryland, United States

Site Status

Forest Research Institute 027

Las Vegas, Nevada, United States

Site Status

Forest Research Institute 050

Salisbury, North Carolina, United States

Site Status

Forest Research Institute 039

Wilmington, North Carolina, United States

Site Status

Forest Investigative Site 002

Charleston, South Carolina, United States

Site Status

Forest Research Institute 032

Greenville, South Carolina, United States

Site Status

Forest Research Institute 008

Nashville, Tennessee, United States

Site Status

Forest Research Institute 003

Carrollton, Texas, United States

Site Status

Forest Research Institute 012

San Antonio, Texas, United States

Site Status

Forest Research Institute 048

Sugar Land, Texas, United States

Site Status

Forest Research Institute 040

Bountiful, Utah, United States

Site Status

Countries

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United States

Related Links

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http://mylan.com

Related Info

Other Identifiers

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NEB-MD-03

Identifier Type: -

Identifier Source: org_study_id

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