Status:
COMPLETED
The CLEVER Study - Coreg And Left Ventricular Mass Regression
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hypertrophy, Left Ventricular
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin convert...
Detailed Description
A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation (COREG MR) and Atenolol in Combination with and Compared to an Angiotensin Converting En...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Stage 1 or Stage 2 hypertension.
- Left ventricular hypertrophy.
- Exclusion criteria:
- In atrial fibrillation.
- Takes beta-blocker for MI (myocardial infarction) or arrhythmia.
- Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease.
- Uses beta-2-agonists.
- Unable to undergo MRI (magnetic resonance imaging).
- Females of childbearing potential.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00108082
Start Date
January 1 2005
End Date
August 1 2008
Last Update
December 16 2016
Active Locations (78)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35235
2
GSK Investigational Site
Birmingham, Alabama, United States, 35249
3
GSK Investigational Site
Mobile, Alabama, United States, 36608
4
GSK Investigational Site
Chandler, Arizona, United States, 77030