CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 318 enrolled
Drug / intervention
carvedilol controlled release +1 moredrug
Likely dose
Carvedilol controlled-release 10–80 mg once daily in morning, or carvedilol immediate-release 3.125–25 mg twice dailyAI-extracted
Key inclusion· 4
  • ✓Stable chronic mild to severe heart failure not requiring IV diuretics, inotropes, vasodilators, or requiring LVAD support
  • ✓LVEF <40% measured by 2-D echocardiography at screening
  • ✓Age ≥18 years at time of informed consent
  • ✓On ACE inhibitor or angiotensin receptor blocker unless contraindicated or intolerant
Key exclusion· 16
  • ✕On beta-blocker therapy for >42 days prior to consent
  • ✕Acute coronary event or revascularization (PTCA, CABG, thrombolysis) within 1 week of screening or scheduled within 4 weeks
  • ✕Unstable angina with sudden changes in severity/frequency or decreased exertional threshold
  • ✕Uncontrolled ventricular arrhythmias (sustained or symptomatic not controlled with therapy or defibrillator)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00323037
NCT00323037Phase 3Completed
CompareCT.gov

A Multicenter,Randomized, Double Blind, Double Dummy, Parallel Group Study to Compare Effects of Coreg CR and Coreg IR on Left Ventricular End Systolic Volume Index in Subjects With Stable Chronic Heart Failure

CTI-1, LLC·interventional·Posted May 9, 2006·Updated Mar 28, 2023

In Brief

A Phase 3 clinical trial evaluating carvedilol controlled release and carvedilol immediate release for Congestive Heart Failure. Completed, enrolled 318 participants across 75 sites.

Detailed Summary

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesUnited States
CollaboratorsCTI Clinical Trial and Consulting Services, GlaxoSmithKline

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2006
Enrollment StartMar 1, 2006
Primary CompletionApr 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.1 years ago

Interventions

carvedilol controlled releasedrug

Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.

carvedilol immediate releasedrug

Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.