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The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

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Forest Laboratories

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease
Hypertension

Treatments

Drug: Carvedilol
Drug: Nebivolol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00673075
NEB-MD-06

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

39 participants in 2 patient groups

1
Active Comparator group
Description:
Encapsulated Nebivolol
Treatment:
Drug: Nebivolol
2
Active Comparator group
Description:
Encapsulated Carvedilol
Treatment:
Drug: Carvedilol

Trial contacts and locations

34

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Data sourced from clinicaltrials.gov

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