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NCT00108082 · ClinicalTrials.gov registry record · Phase 3
The CLEVER Study - Coreg And Left Ventricular Mass Regression
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 287
- Enrollment target
NCT00108082: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00108082 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 287 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00108082, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 287 participants
- Enrollment target
Study 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.
Primary Outcome
LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m\^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
Interventions
- DRUG lisinopril
- DRUG atenolol
- DRUG carvedilol MR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2005-01 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00108082 record still lists
NCT00108082 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which lisinopril is the first listed.
NCT00108082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00108082 about?
NCT00108082 is a clinical study titled "The CLEVER Study - Coreg And Left Ventricular Mass Regression". 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 vent...
What is the current status of trial NCT00108082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2005-01. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00108082?
The interventions under investigation include: lisinopril (DRUG), atenolol (DRUG), carvedilol MR (DRUG).
Who is sponsoring clinical trial NCT00108082?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00108082's enrollment target sits among peer trials
287 1182nd of 2000 higher than 819 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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