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

Primary Purpose

Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Omecamtiv Mecarbil Matrix F1 Formulation
Omecamtiv Mecarbil Matrix F2 Formulation
Placebo
Omecamtiv Mecarbil Swellable Core Technology F2
Sponsored by
Cytokinetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Modified Release Oral Formulation focused on measuring Pharmacokinetics, Omecamtiv mecarbil, AMG 423, Double-blind, Randomized, Placebo-controlled, Oral forumlation, CK-1827452, Cardiac myosin activator

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of chronic heart failure (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 prohormone B-type natriuretic peptide (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 blood pressure > 160 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg
  • Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x ULN
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Dose-escalation Cohort 1: Placebo

Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1

Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2

Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2

Dose-escalation Cohort 2: Placebo

Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1

Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2

Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2

Expansion Phase: Placebo

Expansion Phase: Omecamtiv Mecarbil 25 mg M-F1

Expansion Phase: OM M-F1 PK-based Titration

Arm Description

Participants received placebo tablets twice a day (BID) for 7 days.

Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.

Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.

Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.

Participants received placebo tablets twice a day for 7 days.

Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.

Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.

Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.

Participants received placebo tablets twice a day for 20 weeks.

Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.

All participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.

Outcomes

Primary Outcome Measures

Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7
Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil

Secondary Outcome Measures

Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20
Systolic ejection time was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Expansion Phase: Change From Baseline in Stroke Volume at Week 20
Stroke volume was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20
LVESD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20
LVEDD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Expansion Phase: Change From Baseline in Heart Rate at Week 20
Heart rate was measured using electrocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Expansion Phase: Change From Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) at Week 20
Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: fatal life threatening required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity congenital anomaly/birth defect other medically important serious event
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: fatal life threatening required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity congenital anomaly/birth defect other medically important serious event

Full Information

First Posted
January 18, 2013
Last Updated
July 25, 2021
Sponsor
Cytokinetics
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1. Study Identification

Unique Protocol Identification Number
NCT01786512
Brief Title
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
Acronym
COSMIC-HF
Official Title
A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects With Heart Failure and Left Ventricular Systolic Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2013 (Actual)
Primary Completion Date
July 22, 2015 (Actual)
Study Completion Date
August 19, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.
Detailed Description
Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule that increases cardiac contractility by selectively and directly activating the enzymatic domain of cardiac myosin heavy chain, the force-generating motor protein of the cardiac sarcomere. This is a randomized, placebo-controlled, multicenter, phase 2 study, consisting of a dose escalation phase to select 1 of 3 omecamtiv mecarbil oral formulations in 2 dose escalation cohorts, followed by an expansion phase to evaluate 20 weeks of administration of the selected omecamtiv mecarbil formulation at 2 target dose levels, compared with placebo. This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure, Left Ventricular Ejection Fraction, Pharmacokinetics, Echocardiogram
Keywords
Pharmacokinetics, Omecamtiv mecarbil, AMG 423, Double-blind, Randomized, Placebo-controlled, Oral forumlation, CK-1827452, Cardiac myosin activator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose-escalation Cohort 1: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo tablets twice a day (BID) for 7 days.
Arm Title
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1
Arm Type
Experimental
Arm Description
Participants received 25 mg omecamtiv mecarbil (OM) Matrix F1 (M-F1) tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2
Arm Type
Experimental
Arm Description
Participants received 25 mg omecamtiv mecarbil Matrix F2 (M-F2) tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2
Arm Type
Experimental
Arm Description
Participants received 25 mg omecamtiv mecarbil swellable core technology F2 (SCT-F2) tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 2: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1
Arm Type
Experimental
Arm Description
Participants received 50 mg omecamtiv mecarbil M-F1 tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2
Arm Type
Experimental
Arm Description
Participants received 50 mg omecamtiv mecarbil M-F2 tablets twice a day for 7 days.
Arm Title
Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2
Arm Type
Experimental
Arm Description
Participants received 50 mg omecamtiv mecarbil SCT-F2 tablets twice a day for 7 days.
Arm Title
Expansion Phase: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo tablets twice a day for 20 weeks.
Arm Title
Expansion Phase: Omecamtiv Mecarbil 25 mg M-F1
Arm Type
Experimental
Arm Description
Participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day for 20 weeks.
Arm Title
Expansion Phase: OM M-F1 PK-based Titration
Arm Type
Experimental
Arm Description
All participants received 25 mg omecamtiv mecarbil M-F1 tablets twice a day. At week 8 the dose escalated to 50 mg twice a day if the week 2 predose plasma concentration of OM was less than the predefined cutoff of 200 ng/mL.
Intervention Type
Drug
Intervention Name(s)
Omecamtiv Mecarbil Matrix F1 Formulation
Other Intervention Name(s)
AMG 423, CK-1827452
Intervention Description
Modified release tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Omecamtiv Mecarbil Matrix F2 Formulation
Other Intervention Name(s)
AMG 423, CK-1827452
Intervention Description
Modified release tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Modified release tablets matching to omecamtiv mecarbil
Intervention Type
Drug
Intervention Name(s)
Omecamtiv Mecarbil Swellable Core Technology F2
Other Intervention Name(s)
AMG 423, CK-1827452
Intervention Description
Modified release tablets for oral administration
Primary Outcome Measure Information:
Title
Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Time Frame
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.
Title
Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7)
Time Frame
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours, and 7 days post-dose.
Title
Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7
Time Frame
Day 7 at predose
Title
Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil
Time Frame
Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose
Title
Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing
Time Frame
Predose (before morning dose) at weeks 2, 8, 12, 16, and 20
Title
Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil
Time Frame
Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose.
Secondary Outcome Measure Information:
Title
Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20
Description
Systolic ejection time was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Expansion Phase: Change From Baseline in Stroke Volume at Week 20
Description
Stroke volume was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20
Description
LVESD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20
Description
LVEDD was measured using echocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Expansion Phase: Change From Baseline in Heart Rate at Week 20
Description
Heart rate was measured using electrocardiography. Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Expansion Phase: Change From Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) at Week 20
Description
Least squares means are from a repeated measures model including treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.
Time Frame
Baseline and week 20
Title
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: fatal life threatening required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity congenital anomaly/birth defect other medically important serious event
Time Frame
From first dose of study drug to 4 weeks after last dose; treatment duration was 7 days in the dose escalation phase.
Title
Expansion Phase: Number of Participants With Treatment-emergent Adverse Events
Description
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a preexisting medical condition. The event does not necessarily have a causal relationship with study treatment. Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events. Each adverse event was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, and Grade 4 = life-threatening AE. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: fatal life threatening required in-patient hospitalization or prolongation of existing hospitalization resulted in persistent or significant disability/incapacity congenital anomaly/birth defect other medically important serious event
Time Frame
From first dose of study drug until 4 weeks after last dose; treatment duration was 20 weeks in the expansion phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of chronic heart failure (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 prohormone B-type natriuretic peptide (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 blood pressure > 160 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x ULN Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Research Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Research Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Research Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Research Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Research Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Research Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Research Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
Cortlandt Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-8802
Country
United States
Facility Name
Research Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Research Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Research Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Research Site
City
Pazardzhik
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Sandanski
ZIP/Postal Code
2800
Country
Bulgaria
Facility Name
Research Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Research Site
City
Smolyan
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Research Site
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Research Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 2E8
Country
Canada
Facility Name
Research Site
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
636 00
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
771 11
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Svitavy
ZIP/Postal Code
568 25
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Research Site
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Research Site
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Research Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Research Site
City
Jaszbereny
ZIP/Postal Code
5100
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Research Site
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Research Site
City
Klodzko
ZIP/Postal Code
57-300
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
ZIP/Postal Code
41-703
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-256
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Research Site
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Research Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27914656
Citation
Teerlink JR, Felker GM, McMurray JJ, Solomon SD, Adams KF Jr, Cleland JG, Ezekowitz JA, Goudev A, Macdonald P, Metra M, Mitrovic V, Ponikowski P, Serpytis P, Spinar J, Tomcsanyi J, Vandekerckhove HJ, Voors AA, Monsalvo ML, Johnston J, Malik FI, Honarpour N; COSMIC-HF Investigators. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): a phase 2, pharmacokinetic, randomised, placebo-controlled trial. Lancet. 2016 Dec 10;388(10062):2895-2903. doi: 10.1016/S0140-6736(16)32049-9. Epub 2016 Dec 1.
Results Reference
background
PubMed Identifier
33826209
Citation
Biering-Sorensen T, Minamisawa M, Liu J, Claggett B, Papolos AI, Felker GM, McMurray JJV, Legg JC, Malik FI, Honarpour N, Kurtz CE, Teerlink JR, Solomon SD. The effect of the cardiac myosin activator, omecamtiv mecarbil, on right ventricular structure and function in chronic systolic heart failure (COSMIC-HF). Eur J Heart Fail. 2021 Jun;23(6):1052-1056. doi: 10.1002/ejhf.2181. Epub 2021 May 5. No abstract available.
Results Reference
derived
PubMed Identifier
33176443
Citation
Biering-Sorensen T, Minamisawa M, Claggett B, Liu J, Felker GM, McMurray JJV, Malik FI, Abbasi S, Kurtz CE, Teerlink JR, Solomon SD. Cardiac Myosin Activator Omecamtiv Mecarbil Improves Left Ventricular Myocardial Deformation in Chronic Heart Failure: The COSMIC-HF Trial. Circ Heart Fail. 2020 Dec;13(12):e008007. doi: 10.1161/CIRCHEARTFAILURE.120.008007. Epub 2020 Nov 12. No abstract available.
Results Reference
derived
PubMed Identifier
33176437
Citation
Felker GM, Solomon SD, McMurray JJV, Cleland JGF, Abbasi SA, Malik FI, Zhang H, Globe G, Teerlink JR; COSMIC-HF Investigators. Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study. Circ Heart Fail. 2020 Dec;13(12):e007814. doi: 10.1161/CIRCHEARTFAILURE.120.007814. Epub 2020 Nov 12.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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