Clinical trial NCT00673075: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Coronary Artery Disease
Keywords: carvedilol
Coreg (TM)
hypertension
blood pressure
coronary artery disease
Nebivolol
BYSTOLIC (TM)
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Peripheral Diastolic Blood Pressure (DBP)
timeFrame: 18 weeks post initiation of randomized treatment
Secondary outcomes:
measure: Peripheral Systolic Blood Pressure (SBP)
timeFrame: 18 weeks post initiation of randomized treatment
measure: Proportion of Patients With Peripheral SBP <140 mm Hg and DBP <90 mm Hg at Week 18
timeFrame: 18 weeks post-treatment
measure: Left Ventricular Ejection Fraction (LVEF) (%) at Week 18
timeFrame: 18 weeks post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site
state: Alabama
city: Peoria
country: United States
facility: Forest Investigative Site
state: Arizona
city: Buena Park
country: United States
facility: Forest Investigative Site
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site
state: California
city: Orange
country: United States
facility: Forest Investigative Site
state: California
city: Santa Ana
country: United States
facility: Forest Investigator Site
state: California
city: Guilford
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Coral Gables
country: United States
facility: Forest Investigator Site
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Forest Investigator Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Forest Investigator Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: Winter Haven
country: United States
facility: Forest Investigator Site
state: Florida
city: Chicago
country: United States
facility: Forest Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigator Site
state: Indiana
city: Lafayette
country: United States
facility: Forest Investigator Site
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigator Site
state: Maine
city: Pittsfield
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: Worcester
country: United States
facility: Forest Investigator Site
state: Massachusetts
city: Detroit
country: United States
facility: Forest Investigative Site
state: Michigan
city: Lansing
country: United States
facility: Forest Investigative Site
state: Michigan
city: Las Vegas
country: United States
facility: Forest Investigator Site
state: Nevada
city: Bronx
country: United States
facility: Forest Investigative Site
state: New York
city: Bronx
country: United States
facility: Forest Investigative Site
state: New York
city: Northport
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Lenoir
country: United States
facility: Forest Investigator Site
state: North Carolina
city: Fargo
country: United States
facility: Forest Investigative Site
state: North Dakota
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Lancaster
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Florence
country: United States
facility: Forest Investigator Site
state: South Carolina
city: Cleveland
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Carrollton
country: United States
facility: Forest Investigative Site
state: Texas
Study officials:
affiliation: Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.
name: Tatjana Lukic, MD., M.Sc
role: STUDY_DIRECTOR
References: