Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

This study is double blind (neither the patient nor the physician will know which drug is being administered). Each drug has been approved by the FDA for the treatment of hypertension. The study is being conducted in about 160 patients at approximately 30 research centers in the United States.

The study consists of approximately 18 study visits over a period of 6 months.

During these visits, patients will undergo routine health exams. In addition, exercise test and echocardiogram (an ultrasound of the heart) results will be collected. Information on symptoms, side effects, and how the study drugs are tolerated will also be collected.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Encapsulated Nebivolol
• Active Comparator: 2
  • Encapsulated Carvedilol

Primary Measures

• Peripheral diastolic blood pressure (DBP)
  • Time Frame: 18 weeks post initiation of randomized treatment
    Safety Issue?: No

Secondary Measures

• Peripheral systolic blood pressure (SBP)
  • Time Frame: 18 weeks post initiation of randomized treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Forest Laboratories

Overall Clinical Trial Officials and Contacts

David Bharucha, MD, PhD Study Director Forest Laboratories  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673075

Study ID Number: NEB-MD-06

ClinicalTrials.gov Identifier: NCT00673075

Health Authority: United States: Food and Drug Administration