Trial Outcomes & Findings for A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure (NCT NCT00323037)
NCT ID: NCT00323037
Last Updated: 2023-03-28
Results Overview
Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
318 participants
Primary outcome timeframe
24 weeks after entry into the maintenance period
Results posted on
2023-03-28
Participant Flow
The recruitment period was from April 2006 until August 2007.
Participant milestones
| Measure |
Coreg Immediate Release
|
Coreg Controlled Release
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
153
|
|
Overall Study
COMPLETED
|
132
|
126
|
|
Overall Study
NOT COMPLETED
|
33
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Coreg Immediate Release
n=165 Participants
|
Coreg Controlled Release
n=153 Participants
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
117 participants
n=99 Participants
|
110 participants
n=107 Participants
|
227 participants
n=206 Participants
|
|
Age, Customized
65<=Age<75
|
27 participants
n=99 Participants
|
21 participants
n=107 Participants
|
48 participants
n=206 Participants
|
|
Age, Customized
Age>=75 years
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: Analysis was performed on the modified intent to treat population (mITT), which were those subjects with both a Baseline and an evaluable End of Study echocardiogram.
Maintenance Visit 3 minus Baseline. Maintenance Visit 3 occurred 24 weeks after entry into the maintenance period. The maintenance period started after completion of a titration period of variable duration.
Outcome measures
| Measure |
Carvedilol Immediate Release
n=128 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=125 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVI) Characterized by 2-D Echocardiography
|
-18.36 mL/m^2
Standard Deviation 18.84
|
-20.81 mL/m^2
Standard Deviation 25.43
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=128 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=125 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
|
.08 percentage of change
Standard Deviation .10
|
.08 percentage of change
Standard Deviation .10
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=128 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=125 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Diastolic Volume (LVEDV)
|
-36.61 percentage of change
Standard Deviation 46.27
|
-42.22 percentage of change
Standard Deviation 64.89
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=128 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=125 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Systolic Volume (LVESV)
|
-36.61 percentage of change
Standard Deviation 46.27
|
-43.00 percentage of change
Standard Deviation 53.49
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=128 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=125 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI)
|
-18.29 percentage of change
Standard Deviation 22.61
|
-20.57 percentage of change
Standard Deviation 31.28
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=75 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=79 Participants
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.
|
|---|---|---|
|
Change From Baseline in Intraventricular Septal Thickness (IVST)
|
.08 percentage of change
Standard Deviation .26
|
.05 percentage of change
Standard Deviation .26
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=67 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=69 Participants
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.
|
|---|---|---|
|
Change From Baseline in Posterior Wall Thickness (PWT)
|
.07 percentage of change
Standard Deviation .23
|
.05 percentage of change
Standard Deviation .23
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=59 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=55 Participants
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.
|
|---|---|---|
|
Change From Baseline in Left Ventricular Mass (LVM)
|
9.5 percentage of change
Standard Deviation 113.43
|
-9.29 percentage of change
Standard Deviation 105.06
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=64 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=57 Participants
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.
|
|---|---|---|
|
Change From Baseline in End Diastolic Dimension (EDD)
|
-0.33 percentage of change
Standard Deviation .97
|
-0.36 percentage of change
Standard Deviation .95
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=61 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=55 Participants
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.
|
|---|---|---|
|
Change From Baseline in End Systolic Dimension (ESD)
|
-0.76 percentage of change
Standard Deviation 1.08
|
-0.83 percentage of change
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=92 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=95 Participants
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.
|
|---|---|---|
|
Change From Baseline in Deceleration Time
|
24.00 percentage of change
Standard Deviation 91.71
|
53.37 percentage of change
Standard Deviation 83.74
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=84 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=86 Participants
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.
|
|---|---|---|
|
Change From Baseline in Early to Late Atrial Ratio (E:A Ratio)
|
-0.20 percentage of change
Standard Deviation 0.70
|
-0.45 percentage of change
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance periodPopulation: modified intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=121 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=116 Participants
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.
|
|---|---|---|
|
Change From Baseline in BNP Levels
|
-0.88 percentage of change
Standard Deviation 1.25
|
-0.86 percentage of change
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Up to 32 weeks (titration and maintenance phases)Population: intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=165 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=153 Participants
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.
|
|---|---|---|
|
Incidence of Hospitalizations
Hospitalization for Heart Failure
|
6 participants in each treatment group
|
6 participants in each treatment group
|
|
Incidence of Hospitalizations
Hospitalization Due to Any Cause
|
31 participants in each treatment group
|
29 participants in each treatment group
|
|
Incidence of Hospitalizations
Hospitalization or Death
|
32 participants in each treatment group
|
29 participants in each treatment group
|
SECONDARY outcome
Timeframe: Up to 32 weeks (titration and maintenance phases)Population: intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=165 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=153 Participants
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.
|
|---|---|---|
|
Drug Dose Tolerability
Study Entry (10mg Coreg CR, 3.125mg Coreg IR)
|
79 subjects in each treatment group
|
83 subjects in each treatment group
|
|
Drug Dose Tolerability
Maintenance Entry (10mg Coreg CR, 3.125mg Coreg IR)
|
0 subjects in each treatment group
|
0 subjects in each treatment group
|
|
Drug Dose Tolerability
End of Study (10mg Coreg CR, 3.125mg Coreg IR)
|
7 subjects in each treatment group
|
4 subjects in each treatment group
|
|
Drug Dose Tolerability
Study Entry (20mg Coreg CR, 6.25mg Coreg IR)
|
61 subjects in each treatment group
|
39 subjects in each treatment group
|
|
Drug Dose Tolerability
Maintenance Entry (20mg Coreg CR, 6.25mg Coreg IR)
|
13 subjects in each treatment group
|
9 subjects in each treatment group
|
|
Drug Dose Tolerability
End of Study (20mg Coreg CR, 6.25mg Coreg IR)
|
16 subjects in each treatment group
|
16 subjects in each treatment group
|
|
Drug Dose Tolerability
Study Entry (40mg Coreg CR, 12.5mg Coreg IR)
|
21 subjects in each treatment group
|
27 subjects in each treatment group
|
|
Drug Dose Tolerability
Maintenance Entry (40mg Coreg CR, 12.5mg Coreg IR)
|
12 subjects in each treatment group
|
16 subjects in each treatment group
|
|
Drug Dose Tolerability
End of Study (40mg Coreg CR, 12.5mg Coreg IR)
|
21 subjects in each treatment group
|
22 subjects in each treatment group
|
|
Drug Dose Tolerability
Study Entry (80mg Coreg CR, 25mg Coreg IR)
|
4 subjects in each treatment group
|
4 subjects in each treatment group
|
|
Drug Dose Tolerability
Maintenance Entry (80mg Coreg CR, 25mg Coreg IR)
|
116 subjects in each treatment group
|
114 subjects in each treatment group
|
|
Drug Dose Tolerability
End of Study (80mg Coreg CR, 25mg Coreg IR)
|
121 subjects in each treatment group
|
111 subjects in each treatment group
|
SECONDARY outcome
Timeframe: Up to 32 weeks (titration and maintenance phases)Population: intent to treat subjects
Outcome measures
| Measure |
Carvedilol Immediate Release
n=142 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=132 Participants
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.
|
|---|---|---|
|
Treatment Compliance
<80% compliance
|
4 Participants
|
6 Participants
|
|
Treatment Compliance
80%-120%
|
138 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after entry into the maintenance phase (after unblinding)Population: intent to treat
SAEs experienced
Outcome measures
| Measure |
Carvedilol Immediate Release
n=27 Participants
Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.
|
Carvedilol Controlled Release
n=27 Participants
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.
|
|---|---|---|
|
Safety and Tolerability of Coreg CR
|
40 number of SAEs
|
35 number of SAEs
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sandy Stagge, RN, BSN
CTI Clinical Trial and Consulting Services
Phone: 513-619-1837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The publishing party will submit any proposed manuscript or publication to the sponsor for comment at least 60 days prior to its release. The publishing party will make every reasonable attempt to incorporate comments received from the sponsor, and will upon request remove any previously undisclosed confidential information, prior to publication or disclosure. There will be no publication or publicizing of individual site data or results prior to the multicenter publication.
- Publication restrictions are in place
Restriction type: OTHER