The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673075
• Other study ID #: NEB-MD-06
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: September 2, 2010
• Start date: May 2008

Study information

• Verified date: September 2010
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypertension
• Myocardial Ischemia

Intervention

Drug:
• Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
• Carvedilol
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Locations

Country	Name	City	State
United States	Forest Investigator Site	Auburn	Maine
United States	Forest Investigative Site	Birmingham	Alabama
United States	Forest Investigative Site	Bronx	New York
United States	Forest Investigative Site	Bronx	New York
United States	Forest Investigative Site	Buena Park	California
United States	Forest Investigative Site	Carrollton	Texas
United States	Forest Investigative Site	Charleston	South Carolina
United States	Forest Investigative Site	Charlotte	North Carolina
United States	Forest Investigative Site	Chicago	Illinois
United States	Forest Investigative Site	Cincinnati	Ohio
United States	Forest Investigative Site	Cleveland	Tennessee
United States	Forest Investigator Site	Coral Gables	Florida
United States	Forest Investigative Site	Daytona Beach	Florida
United States	Forest Investigative Site	Detroit	Michigan
United States	Forest Investigative Site	Fargo	North Dakota
United States	Forest Investigator Site	Florence	South Carolina
United States	Forest Investigative Site	Guilford	Connecticut
United States	Forest Investigator Site	Hollywood	Florida
United States	Forest Investigator Site	Indianapolis	Indiana
United States	Forest Investigator Site	Lafayette	Louisiana
United States	Forest Investigative Site	Lancaster	Pennsylvania
United States	Forest Investigative Site	Lansing	Michigan
United States	Forest Investigator Site	Las Vegas	Nevada
United States	Forest Investigator Site	Lenoir	North Carolina
United States	Forest Investigative Site	Los Angeles	California
United States	Forest Investigator Site	New Smyrna Beach	Florida
United States	Forest Investigative Site	Northport	New York
United States	Forest Investigative Site	Orange	California
United States	Forest Investigative Site	Orlando	Florida
United States	Forest Investigative Site	Peoria	Arizona
United States	Forest Investigative Site	Pittsfield	Massachusetts
United States	Forest Investigator Site	Santa Ana	California
United States	Forest Investigator Site	Winter Haven	Florida
United States	Forest Investigator Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral Diastolic Blood Pressure (DBP)	Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)	18 weeks post initiation of randomized treatment	No
Secondary	Peripheral Systolic Blood Pressure (SBP)	Peripheral systolic blood pressure (SBP) at visit 13 (week 18)	18 weeks post initiation of randomized treatment	No
Secondary	Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18	Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18	18 weeks post-treatment	No
Secondary	Left Ventricular Ejection Fraction (LVEF) (%) at Week 18	Left ventricular ejection fraction (LVEF) (%) at Week 18	18 weeks post-treatment	No