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=5 Participants	110 participants n=7 Participants	227 participants n=5 Participants
Age, Customized 65<=Age<75	27 participants n=5 Participants	21 participants n=7 Participants	48 participants n=5 Participants
Age, Customized Age>=75 years	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	45 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants	108 Participants n=7 Participants	221 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks after entry into the maintenance period

Population: 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	Coreg Immediate Release n=128 Participants	Coreg Controlled Release n=125 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=128 Participants	Coreg Controlled Release n=125 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=128 Participants	Coreg Controlled Release n=125 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=128 Participants	Coreg Controlled Release n=125 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=128 Participants	Coreg Controlled Release n=125 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=75 Participants	Coreg Controlled Release n=79 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=67 Participants	Coreg Controlled Release n=69 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=59 Participants	Coreg Controlled Release n=55 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=64 Participants	Coreg Controlled Release n=57 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=61 Participants	Coreg Controlled Release n=55 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=92 Participants	Coreg Controlled Release n=95 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=84 Participants	Coreg Controlled Release n=86 Participants
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 period

Population: modified intent to treat subjects

Outcome measures

Measure	Coreg Immediate Release n=121 Participants	Coreg Controlled Release n=116 Participants
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	Coreg Immediate Release n=165 Participants	Coreg Controlled Release n=153 Participants
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	Coreg Immediate Release n=165 Participants	Coreg Controlled Release n=153 Participants
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 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 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	Coreg Immediate Release n=142 Participants	Coreg Controlled Release n=132 Participants
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	Coreg Immediate Release n=27 Participants	Coreg Controlled Release n=27 Participants
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: sstagge@ctifacts.com

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