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The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

This study has been completed.
Information provided by:
Forest Laboratories Identifier:
First received: April 29, 2008
Last updated: September 2, 2010
Last verified: September 2010
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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:

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 ]
    Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)

Secondary Outcome Measures:
  • Peripheral Systolic Blood Pressure (SBP) [ Time Frame: 18 weeks post initiation of randomized treatment ]
    Peripheral systolic blood pressure (SBP) at visit 13 (week 18)

  • Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18 [ Time Frame: 18 weeks post-treatment ]
    Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18

  • Left Ventricular Ejection Fraction (LVEF) (%) at Week 18 [ Time Frame: 18 weeks post-treatment ]
    Left ventricular ejection fraction (LVEF) (%) at Week 18

Enrollment: 39
Study Start Date: May 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Encapsulated Nebivolol
Drug: Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
Other Name: Bystolic
Active Comparator: 2
Encapsulated Carvedilol
Drug: Carvedilol
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Other Name: Coreg


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00673075

  Show 34 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: Tatjana Lukic, MD., M.Sc Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.
  More Information

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc. Identifier: NCT00673075     History of Changes
Other Study ID Numbers: NEB-MD-06
Study First Received: April 29, 2008
Results First Received: September 2, 2010
Last Updated: September 2, 2010

Keywords provided by Forest Laboratories:
Coreg (TM)
blood pressure
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arterial Occlusive Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists processed this record on June 23, 2017