Trial · NCT01786512
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
NCT01786512, Phase 2, Completed, Cytokinetics; results first posted 2021-05-17
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure. Trials, record NCT01786512. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01786512
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
- NCT number
- NCT01786512
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 544 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure, Left Ventricular Ejection Fraction, Pharmacokinetics, Echocardiogram
- Interventions
- Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, Placebo, Omecamtiv Mecarbil Swellable Core Technology F2
- First posted
- 2013-02-08
- Last updated
- 2021-08-12
- Other registries' IDs
- eudract:2012-000327-40
- Results first posted
- 2021-05-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | 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. | |
| Primary | Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | 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. | |
| Primary | Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7 | Day 7 at predose | |
| Primary | Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil | Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose | |
| Primary | Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing | Predose (before morning dose) at weeks 2, 8, 12, 16, and 20 | |
| Primary | Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil | Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose. | |
| Secondary | Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20 | Baseline and 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. |
| Secondary | Expansion Phase: Change From Baseline in Stroke Volume at Week 20 | Baseline and 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. |
| Secondary | Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20 | Baseline and 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. |
| Secondary | Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20 | Baseline and 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | 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. | The pharmacokinetic analysis set (PKAS) included all randomized participants who received at least 1 dose of OM and had at least 1 evaluable OM PK parameter. | ng/mL | MEAN |
| PRIMARY | Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | 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. | Pharmacokinetic analysis set | hours | MEAN |
| PRIMARY | Dose Escalation Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing on Day 7 | Day 7 at predose | Pharmacokinetic analysis set | ng/mL | MEAN |
| PRIMARY | Dose Escalation Phase: Area Under the Plasma Concentration-time Curve for a Dosing Interval of 12 Hours Post Dose (AUC12) for Omecamtiv Mecarbil | Day 7 at predose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose | Pharmacokinetic analysis set | ng*hr/mL | MEAN |
| PRIMARY | Expansion Phase: Plasma Concentration of Omecamtiv Mecarbil Prior to Dosing | Predose (before morning dose) at weeks 2, 8, 12, 16, and 20 | Pharmacokinetic analysis set with available data at each time point. | ng/mL | MEAN |
| PRIMARY | Expansion Phase: Maximum Observed Plasma Concentration of Omecamtiv Mecarbil | Weeks 2 and 12 at predose and 1, 2, 4, 6, and 8 hours post-dose. | Pharmacokinetic analysis set with available data at each time point. | ng/mL | MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Systolic Ejection Time (SET) at Week 20 | Baseline and week 20 | The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Stroke Volume at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | mL | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Left Ventricular End Systolic Diameter (LVESD) at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Expansion Phase: Change From Baseline in Left Ventricular End Diastolic Diameter (LVEDD) at Week 20 | Baseline and week 20 | The full analysis set included all randomized participants who received at least 1 dose of study drug. The repeated-measures model included all observed values. | cm | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | 193 | Standard Deviation 58.8 | ng/mL | |
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | 201 | Standard Deviation 94.4 | ng/mL | |
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | 171 | Standard Deviation 53.8 | ng/mL | |
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | 492 | Standard Deviation 115 | ng/mL | |
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2 | 502 | Standard Deviation 138 | ng/mL | |
| Dose Escalation Phase: Maximum Observed Plasma Concentration (Cmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2 | 601 | Standard Deviation 204 | ng/mL | |
| Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | 3.9 | Standard Deviation 4.4 | hours | |
| Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | 2.0 | Standard Deviation 1.2 | hours | |
| Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | 4.2 | Standard Deviation 1.9 | hours | |
| Dose Escalation Phase: Time to Maximum Observed Plasma Concentration (Tmax) of Omecamtiv Mecarbil Following the Last Dose (Day 7) | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | 2.6 | Standard Deviation 2.4 | hours |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-escalation Cohort 1: Placebo | 11 | |
| Overall Study | STARTED | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | 11 | |
| Overall Study | STARTED | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | 14 | |
| Overall Study | STARTED | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | 13 | |
| Overall Study | STARTED | Dose-escalation Cohort 2: Placebo | 10 | |
| Overall Study | STARTED | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | 11 | |
| Overall Study | STARTED | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2 | 12 | |
| Overall Study | STARTED | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2 | 14 | |
| Overall Study | STARTED | Expansion Phase: Placebo | 149 | |
| Overall Study | STARTED | Expansion Phase: Omecamtiv Mecarbil 25 mg | 150 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events1,408
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 1: Placebo | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 2: Placebo | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2 | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2 | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Phase: Placebo | 1 | 149 | |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Phase: Omecamtiv Mecarbil 25 mg | 0 | 150 |
1 to 10 of 1,408Source ClinicalTrials.gov
See all 1,408 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-escalation Cohort 1: Placebo | ||
| Total, all-cause mortality | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F1 | ||
| Total, all-cause mortality | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg M-F2 | ||
| Total, all-cause mortality | Dose-escalation Cohort 1: Omecamtiv Mecarbil 25 mg SCT-F2 | ||
| Total, all-cause mortality | Dose-escalation Cohort 2: Placebo | ||
| Total, all-cause mortality | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F1 | ||
| Total, all-cause mortality | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg M-F2 | ||
| Total, all-cause mortality | Dose-escalation Cohort 2: Omecamtiv Mecarbil 50 mg SCT-F2 | ||
| Total, all-cause mortality | Expansion Phase: Placebo | ||
| Total, all-cause mortality | Expansion Phase: Omecamtiv Mecarbil 25 mg |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01786512
GET https://conductscience.org/api/trials/v1/NCT01786512/results?page=2