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Study Complete
Sponsor ID
20110151

COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure.COSMIC-HF

Sponsor ID
20110151
Clinicaltrials.gov ID
NCT01786512
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects with HF and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

Additional Study Details

Phase
Phase 2
Product
omecamtiv mecarbil
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
544
Additional Study Details

Protocol Summary

Primary Outcome Measures

Dose Escalation - Characterize Pharmacokinetics - Cmax

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 96, 120 hours after first dose; 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 168 hours following dose on day 7

Dose Escalation - Characterize Pharmacokinetics -Cmin

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 96, 120 hours after first dose; 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 168 hours following dose on day 7

Dose Escalation - Characterize Pharmacokinetics-Tmax

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 96, 120 hours after first dose; 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 168 hours following dose on day 7

Dose Escalation - Characterize Pharmacokinetics - AUC12h

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 hours after first dose; 0, 0.5, 1, 2, 3, 4, 6, 8, 12 hours following dose on day 7

Dose Expansion - Characterize Pharmacokinetics - Cmax

Timeframe: predose, predose, 1 , 2, 4, 6, and 8 hours after morning dose on weeks 2 and 12; predose, between 1-4 hours post dose on week 20

Dose Expansion - Characterize Pharmacokinetics - Cpredose

Timeframe: predose before morning dose on Day1, weeks 2, 8 , 12, 16 and 20

Secondary Outcome Measures

Systolic Ejection Time(SET) (msec)

Timeframe: baseline and 20 weeks

Left Ventricular End-Systolic Diameter (LVESD) (cm)

Timeframe: baseline and 20 weeks

Left Ventricular End-Diastolic Diameter (LVEDD) (cm)

Timeframe: baseline and 20 weeks

Heart Rate (beats per minute)

Timeframe: baseline and 20 weeks

Stroke Volume (ml)

Timeframe: baseline and 20 weeks

Effect of omecamtiv mecarbil on NT-proBNP (pg/mL)

Timeframe: baseline and 20 weeks

Dose Escalation - Safety and tolerability of oral omecamtiv mecarbil

Timeframe: baseline to 35 days

Dose Expansion - Safety and tolerability of oral omecamtiv mecarbil

Timeframe: baseline to 24 weeks

Study Documents

Plain Language Summary of Results
Available Language(s): English, Hungarian, Italian, Lithuanian, French (Canadian), Bulgarian, Czech, German, Spanish, French (Belgium), Russian, Polish, Dutch
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Tullahoma, TN, United States, 37388
Status
Recruiting
Location
Research Site
Moblie, AL, United States, 36608
Status
Recruiting
Location
Research Site
Costa Mesa, CA, United States, 92626
Status
Recruiting
Location
Research Site
Atlantis, FL, United States, 33462
Status
Recruiting
Location
Research Site
Aventura, FL, United States, 33180
Status
Recruiting
Location
Research Site
Macon, GA, United States, 31201
Status
Recruiting
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Study Info
Age
18 - 85 Years
Condition
  • Heart Failure
    • Sex
    All
    Trial Dates
    Feb 2013 - Jul 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - History of chronic HF, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening - Treated with stable, optimal pharmacological therapy for ≥ 4 weeks - History of left ventricular ejection fraction (LVEF) ≤ 40% - Elevated N-terminal fragment BNP (NT-proBNP)
    Exclusion Criteria:
    - Severe uncorrected valvular heart disease - Hospitalization within 30 days prior to enrollment - Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease - Acute Myocardial Infarction, Unstable angina or persistent angina at rest within 30 days prior to randomization - Systolic BP > 160 mmHg or < 90 mmHg or diastolic BP > 90 mmHg - TBL ≥ 2x ULN; AST or ALT ≥ 3x ULN - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2