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The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00673075
First received: April 29, 2008
Last updated: September 2, 2010
Last verified: September 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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 ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov 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
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertension
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Carvedilol
Nebivolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on June 13, 2013