We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673075
First Posted: May 7, 2008
Last Update Posted: September 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forest Laboratories
  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
Intervention Model: Parallel Assignment
Masking: Double (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 29, 2008
First Posted: May 7, 2008
Results First Submitted: September 2, 2010
Results First Posted: September 28, 2010
Last Update Posted: September 28, 2010
Last Verified: September 2010

Keywords provided by Forest Laboratories:
carvedilol
Coreg (TM)
hypertension
blood pressure
coronary artery disease
Nebivolol
BYSTOLIC (TM)

Additional relevant MeSH terms:
Hypertension
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Carvedilol
Nebivolol
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