The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Phase 4

Completed

• Conditions: Hypertension; Coronary Artery Disease
• Interventions: Drug: Nebivolol; Drug: Carvedilol

• Registration Number: NCT00673075
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-29
• Study Start: 2008-05
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-07
• Primary Completion: 2009-09
• Status Verified: 2010-09
• Results First Submitted: 2010-09-02
• Results First Submitted QC: 2010-09-02
• Last Update Submitted: 2010-09-02
• Results First Posted: 2010-09-28
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nebivolol	Encapsulated Nebivolol
2	Carvedilol	Encapsulated Carvedilol

Primary Outcome Measures

Name	Time	Method
Peripheral Diastolic Blood Pressure (DBP)	18 weeks post initiation of randomized treatment	Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Forest Investigative Site; 🇺🇸 Carrollton, Texas, United States

Forest Investigator Site; 🇺🇸 Florence, South Carolina, United States