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The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

Primary Purpose

Hypertension, Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol
Carvedilol
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigator Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigator Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Encapsulated Nebivolol

Encapsulated Carvedilol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Peripheral Systolic Blood Pressure (SBP)
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
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
Left ventricular ejection fraction (LVEF) (%) at Week 18

Full Information

First Posted
April 29, 2008
Last Updated
September 2, 2010
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00673075
Brief Title
The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease
Official Title
Efficacy and Tolerability of Nebivolol Compared With Carvedilol in Patients With Coronary Artery Disease and Stage I or II Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Coronary Artery Disease
Keywords
carvedilol, Coreg (TM), hypertension, blood pressure, coronary artery disease, Nebivolol, BYSTOLIC (TM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Encapsulated Nebivolol
Arm Title
2
Arm Type
Active Comparator
Arm Description
Encapsulated Carvedilol
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
Bystolic
Intervention Description
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration once daily
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
Coreg
Intervention Description
Encapsulated Carvedilol 12.5 mg, 25 mg, 50 mg total daily dosage, oral administration twice daily
Primary Outcome Measure Information:
Title
Peripheral Diastolic Blood Pressure (DBP)
Description
Peripheral diastolic blood pressure (DBP) at post-baseline (visit 13, week 18)
Time Frame
18 weeks post initiation of randomized treatment
Secondary Outcome Measure Information:
Title
Peripheral Systolic Blood Pressure (SBP)
Description
Peripheral systolic blood pressure (SBP) at visit 13 (week 18)
Time Frame
18 weeks post initiation of randomized treatment
Title
Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Description
Proportion of Patients with Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
Time Frame
18 weeks post-treatment
Title
Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
Description
Left ventricular ejection fraction (LVEF) (%) at Week 18
Time Frame
18 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatjana Lukic, MD., M.Sc
Organizational Affiliation
Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Forest Investigative Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Forest Investigative Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Forest Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Forest Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigator Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Forest Investigative Site
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Forest Investigator Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Forest Investigative Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Forest Investigator Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Forest Investigator Site
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Forest Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigator Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Forest Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Forest Investigator Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Forest Investigator Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Forest Investigator Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Forest Investigative Site
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Forest Investigator Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Forest Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Forest Investigative Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Forest Investigator Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Forest Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Forest Investigative Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Forest Investigative Site
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Forest Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Forest Investigator Site
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Forest Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Forest Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Forest Investigator Site
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Forest Investigative Site
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37312
Country
United States
Facility Name
Forest Investigative Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease

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