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OpenTrials
Completed

NCT Number: NCT00673075

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

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.

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Key information

Conditions

Hypertension Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily

Other names: Bystolic

Carvedilol

Drug

Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily

Other names: Coreg

Primary outcomes

  1. 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 outcomes

  1. Peripheral Systolic Blood Pressure (SBP)

    Time frame: 18 weeks post initiation of randomized treatment

    Peripheral systolic blood pressure (SBP) at visit 13 (week 18)

  2. 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

  3. Left Ventricular Ejection Fraction (LVEF) (%) at Week 18

    Time frame: 18 weeks post-treatment

    Left ventricular ejection fraction (LVEF) (%) at Week 18

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension

Important dates

Study start
2008
Primary completion
2009
First posted
May 7, 2008
Registry last updated
Sep 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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