Phase 4 N=39 Randomized Double-blind Treatment

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Hypertension · Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT00673075 ↗

Enrolled (actual)

Serious AEs

1.6%

Results posted

Sep 2010

Primary outcome: Primary: Peripheral Diastolic Blood Pressure (DBP) — 81.1; 78.2; 78.0; 79.3 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nebivolol (Drug); Carvedilol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Peripheral Diastolic Blood Pressure (DBP)	81.1; 78.2; 78.0; 79.3	—
SECONDARY Peripheral Systolic Blood Pressure (SBP)	135.1; 136.9; 129.6; 137.3	—
SECONDARY Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18	11; 5	—
SECONDARY Left Ventricular Ejection Fraction (LVEF) (%) at Week 18	61.43; 60.442; 61.93; 60.775	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00673075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.