The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

NCT ID: NCT00673075

Last Updated: 2010-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.

Detailed Description

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Conditions

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Hypertension Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Encapsulated Nebivolol

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily

2

Encapsulated Carvedilol

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Interventions

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Nebivolol

Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily

Intervention Type DRUG

Carvedilol

Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Intervention Type DRUG

Other Intervention Names

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Bystolic Coreg

Eligibility Criteria

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Inclusion Criteria

* Male or female ambulatory outpatients 18 to 85 of age at screening
* Coronary artery disease as defined by: status post myocardial infarction (heart attack) greater than 14 days post event with no upper time limit (and followed by stress testing with additional imaging (echocardiographic or nuclear) within the 12 months prior to enrollment) and/or angiographic evidence of one or more major coronary arteries narrowing of greater than 50% and/or a history of percutaneous or surgical coronary revascularization greater than 4 months after that procedure at the time of enrollment.
* Qualifying blood pressure criteria for study entry and for randomization
* Willing to adhere to exercise stress (treadmill) tests

Exclusion Criteria

* Unstable angina within 7 days of screening
* Potential coronary surgical/intervention within the next 6 months
* Have any form of secondary hypertension
* Have a history of hypersensitivity to nebivolol, metoprolol, carvedilol, or any beta blocker
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Research Institute, a subsidiary of Forest Laboratories Inc.

Principal Investigators

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Tatjana Lukic, MD., M.Sc

Role: STUDY_DIRECTOR

Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

Locations

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Forest Investigative Site

Birmingham, Alabama, United States

Site Status

Forest Investigative Site

Peoria, Arizona, United States

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Forest Investigative Site

Buena Park, California, United States

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Forest Investigative Site

Los Angeles, California, United States

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Orange, California, United States

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Santa Ana, California, United States

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Forest Investigative Site

Guilford, Connecticut, United States

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Forest Investigator Site

Coral Gables, Florida, United States

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Forest Investigative Site

Daytona Beach, Florida, United States

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Hollywood, Florida, United States

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New Smyrna Beach, Florida, United States

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Forest Investigative Site

Orlando, Florida, United States

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Winter Haven, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Lafayette, Louisiana, United States

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Auburn, Maine, United States

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Pittsfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Las Vegas, Nevada, United States

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Northport, New York, United States

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The Bronx, New York, United States

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Forest Investigative Site

The Bronx, New York, United States

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Forest Investigative Site

Charlotte, North Carolina, United States

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Forest Investigator Site

Lenoir, North Carolina, United States

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Forest Investigative Site

Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Lancaster, Pennsylvania, United States

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Charleston, South Carolina, United States

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Florence, South Carolina, United States

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Forest Investigative Site

Cleveland, Tennessee, United States

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Forest Investigative Site

Carrollton, Texas, United States

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Countries

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United States

Other Identifiers

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NEB-MD-06

Identifier Type: -

Identifier Source: org_study_id