The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

September 2, 2010 updated by: Forest Laboratories

Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

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, 35294
        • Forest Investigative Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site
    • California
      • Buena Park, California, United States, 90620
        • Forest Investigative Site
      • Los Angeles, California, United States, 90048
        • Forest Investigative Site
      • Orange, California, United States, 92868
        • Forest Investigative Site
      • Santa Ana, California, United States, 92705
        • Forest Investigator Site
    • Connecticut
      • Guilford, Connecticut, United States, 06437
        • Forest Investigative Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Forest Investigator Site
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site
      • Hollywood, Florida, United States, 33021
        • Forest Investigator Site
      • New Smyrna Beach, Florida, United States, 32168
        • Forest Investigator Site
      • Orlando, Florida, United States, 32803
        • Forest Investigative Site
      • Winter Haven, Florida, United States, 33880
        • Forest Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Forest Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Forest Investigator Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Forest Investigator Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigator Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Forest Investigative Site
      • Worcester, Massachusetts, United States, 01655
        • Forest Investigator Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Forest Investigative Site
      • Lansing, Michigan, United States, 48910
        • Forest Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Forest Investigator Site
    • New York
      • Bronx, New York, United States, 10451
        • Forest Investigative Site
      • Bronx, New York, United States, 10468
        • Forest Investigative Site
      • Northport, New York, United States, 11768
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Forest Investigative Site
      • Lenoir, North Carolina, United States, 28645
        • Forest Investigator Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
        • Forest Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Forest Investigative Site
      • Florence, South Carolina, United States, 29501
        • Forest Investigator Site
    • Tennessee
      • Cleveland, Tennessee, United States, 37312
        • Forest Investigative Site
    • Texas
      • Carrollton, Texas, United States, 75006
        • Forest Investigative Site

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 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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Encapsulated Nebivolol
Drug: Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
Other Names:
  • Bystolic
ACTIVE_COMPARATOR: 2
Encapsulated Carvedilol
Drug: Carvedilol
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Other Names:
  • Coreg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral Diastolic Blood Pressure (DBP)
Time Frame: 18 weeks post initiation of randomized treatment
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)
18 weeks post initiation of randomized treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral Systolic Blood Pressure (SBP)
Time Frame: 18 weeks post initiation of randomized treatment
Peripheral systolic blood pressure (SBP) at visit 13 (week 18)
18 weeks post initiation of randomized treatment
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Time Frame: 18 weeks post-treatment
Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
18 weeks post-treatment
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
Time Frame: 18 weeks post-treatment
Left ventricular ejection fraction (LVEF) (%) at Week 18
18 weeks post-treatment

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Investigators

  • Study Director: Tatjana Lukic, MD., M.Sc, Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

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

May 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (ESTIMATE)

May 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-06

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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