A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure - Study Results

A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure (COMPARE)

This study has been completed.

Study NCT00323037 Information provided by CTI-1, LLC

First Received: May 5, 2006 Last Updated: March 12, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition:	Congestive Heart Failure
Interventions:	Drug: carvedilol controlled release Drug: carvedilol immediate release

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from April 2006 until August 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Coreg Immediate Release	No text entered.
Coreg Controlled Release	No text entered.

Participant Flow: Overall Study

	Coreg Immediate Release	Coreg Controlled Release
STARTED	165^[1]	153^[2]
COMPLETED	132	126
NOT COMPLETED	33	27

[1]	Number randomized
[2]	Number randomized

Baseline Characteristics

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Reporting Groups

	Description
Coreg Immediate Release	No text entered.
Coreg Controlled Release	No text entered.

Baseline Measures

	Coreg Immediate Release	Coreg Controlled Release	Total
Number of Participants [units: participants]	165	153	318
Age, Customized [units: participants]
< 65 years	117	110	227
65<=Age<75	27	21	48
Age>=75 years	21	22	43
Gender [units: participants]
Female	52	45	97
Male	113	108	221

Outcome Measures

1. Primary:

Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography [ 24 weeks after entry into the maintenance period ]

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