The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00673075

Purpose

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.

Condition	Intervention	Phase
Hypertension Coronary Artery Disease	Drug: Nebivolol Drug: Carvedilol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease High Blood Pressure

Drug Information available for: Carvedilol Nebivolol

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Peripheral diastolic blood pressure (DBP) [ Time Frame: 18 weeks post initiation of randomized treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peripheral systolic blood pressure (SBP) [ Time Frame: 18 weeks post initiation of randomized treatment ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	May 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Encapsulated Nebivolol	Drug: Nebivolol Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
2: Active Comparator Encapsulated Carvedilol	Drug: Carvedilol Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673075

Show 24 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

David Bharucha, MD, PhD

Forest Laboratories

More Information

No publications provided

Responsible Party:	Forest Research Institute, a subsidiary of Forest Laboratories Inc. ( Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory )
Study ID Numbers:	NEB-MD-06
Study First Received:	April 29, 2008
Last Updated:	May 26, 2009
ClinicalTrials.gov Identifier:	NCT00673075 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

carvedilol
Coreg (TM)
hypertension
blood pressure

coronary artery disease
Nebivolol
BYSTOLIC (TM)

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Vasodilator Agents
Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Nebivolol
Adrenergic alpha-Antagonists
Cardiovascular Agents

Arteriosclerosis
Antihypertensive Agents
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Coronary Artery Disease
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on November 20, 2009