The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

NCT00673075 | Completed Phase 4 Results

• 1 other identifier: NEB-MD-06
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 34

Brief Summary

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.

Conditions

Hypertension; Coronary Artery Disease

Keywords

carvedilol; Coreg (TM); hypertension; blood pressure; coronary artery disease; Nebivolol; BYSTOLIC (TM)

Outcome Measures

Primary Outcomes (1)

• Peripheral Diastolic Blood Pressure (DBP)

  Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

  18 weeks post initiation of randomized treatment

Secondary Outcomes (3)

• Peripheral Systolic Blood Pressure (SBP)

  18 weeks post initiation of randomized 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

  18 weeks post-treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Encapsulated Nebivolol

Drug: Nebivolol

2

ACTIVE COMPARATOR

Encapsulated Carvedilol

Drug: Carvedilol

Interventions

Nebivolol DRUG

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

Also known as: Bystolic

1

Carvedilol DRUG

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

Also known as: Coreg

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (34)

Forest Investigative Site

Birmingham, Alabama, 35294, United States

Location

Forest Investigative Site

Peoria, Arizona, 85381, United States

Location

Forest Investigative Site

Buena Park, California, 90620, United States

Location

Forest Investigative Site

Los Angeles, California, 90048, United States

Location

Forest Investigative Site

Orange, California, 92868, United States

Location

Forest Investigator Site

Santa Ana, California, 92705, United States

Location

Forest Investigative Site

Guilford, Connecticut, 06437, United States

Location

Forest Investigator Site

Coral Gables, Florida, 33134, United States

Location

Forest Investigative Site

Daytona Beach, Florida, 32117, United States

Location

Forest Investigator Site

Hollywood, Florida, 33021, United States

Location

Forest Investigator Site

New Smyrna Beach, Florida, 32168, United States

Location

Forest Investigative Site

Orlando, Florida, 32803, United States

Location

Forest Investigator Site

Winter Haven, Florida, 33880, United States

Location

Forest Investigative Site

Chicago, Illinois, 60611, United States

Location

Forest Investigator Site

Indianapolis, Indiana, 46254, United States

Location

Forest Investigator Site

Lafayette, Louisiana, 70503, United States

Location

Forest Investigator Site

Auburn, Maine, 04210, United States

Location

Forest Investigative Site

Pittsfield, Massachusetts, 01201, United States

Location

Forest Investigator Site

Worcester, Massachusetts, 01655, United States

Location

Forest Investigative Site

Detroit, Michigan, 48202, United States

Location

Forest Investigative Site

Lansing, Michigan, 48910, United States

Location

Forest Investigator Site

Las Vegas, Nevada, 89119, United States

Location

Forest Investigative Site

Northport, New York, 11768, United States

Location

Forest Investigative Site

The Bronx, New York, 10451, United States

Location

Forest Investigative Site

The Bronx, New York, 10468, United States

Location

Forest Investigative Site

Charlotte, North Carolina, 28211, United States

Location

Forest Investigator Site

Lenoir, North Carolina, 28645, United States

Location

Forest Investigative Site

Fargo, North Dakota, 58103, United States

Location

Forest Investigative Site

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site

Lancaster, Pennsylvania, 17603, United States

Location

Forest Investigative Site

Charleston, South Carolina, 29401, United States

Location

Forest Investigator Site

Florence, South Carolina, 29501, United States

Location

Forest Investigative Site

Cleveland, Tennessee, 37312, United States

Location

Forest Investigative Site

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Hypertension; Coronary Artery Disease

Interventions

Nebivolol; Carvedilol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propanolamines; Propanols; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

The study was terminated early because of difficulties with enrollment. Only 39 out of 160 planned patients were randomized.

Results Point of Contact

• Title: John Whalen, MD Executive Director of Clinical Development - Cardiovascular and Metabolism
• Organization: Forest Laboratories

John.Whalen@frx.com

1-201-427-8259

Study Officials

• Tatjana Lukic, MD., M.Sc

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: September 28, 2010
• Results First Posted: September 28, 2010

Record last verified: 2010-09

Locations

US (34)