Trials / Completed
CompletedNCT00108082
The CLEVER Study - Coreg And Left Ventricular Mass Regression
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 Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in Hypertensive Patients With Left Ventricular Hypertrophy (LVH).
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 287 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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 converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.
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 Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in Hypertensive Patients with Left Ventricular Hypertrophy (LVH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carvedilol MR | Study drug |
| DRUG | atenolol | Comparator |
| DRUG | lisinopril | Comparator |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2005-04-14
- Last updated
- 2016-12-16
- Results posted
- 2009-11-09
Locations
78 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00108082. Inclusion in this directory is not an endorsement.