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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 287 participants.

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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.

Interventions

  • DRUG lisinopril
  • DRUG atenolol
  • DRUG carvedilol MR

Trial Details

FieldValue
Enrollment Target 287 participants
Start Date 2005-01
Est. Completion 2008-08
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00108082

The ClinicalTrials.gov registry entry for NCT00108082 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which lisinopril is the first listed.

NCT00108082 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.