Trial · NCT02695420
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
NCT02695420, Phase 2, Completed, Cytokinetics; results first posted 2020-01-31
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction. Trials, record NCT02695420. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02695420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
- NCT number
- NCT02695420
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- 25 mg Omecamtiv Mecarbil, Placebo, 37.5 mg Omecamtiv Mecarbil, 50 mg Omecamtiv Mecarbil
- First posted
- 2016-03-01
- Last updated
- 2021-07-27
- Results first posted
- 2020-01-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112) | |
| Primary | PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8) | Week 8 (Day 56) at predose, at 2 hours ±30 minutes; 4 hours ±30 minutes; 6 hours ±30 minutes; 8 hours ±30 minutes after morning dose | |
| Secondary | Change From Baseline at Week 16 in Systolic Ejection Time (SET) | Baseline, Week 16 (Day 112) | LS mean was from the repeated measures model, which included treatment group, stratification factor (from IVRS), scheduled visit, baseline value, and the interaction of treatment group with scheduled visit as covariates. |
| Other | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to Week 20 (Day 140 + 3 days) | An adverse event (AE) is defined as any untoward medical occurrence. Serious AEs are defined as AEs that meets at least 1 of the following serious criteria: fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important serious event. AEs are graded as: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. TEAEs are defined as events occurring after the first dose of study drug. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112) | PK Analysis Set: all randomized participants who received at least one dose of omecamtiv mecarbil and had at least one evaluable omecamtiv mecarbil PK concentration at given time point. | ng/mL | MEAN |
| PRIMARY | PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8) | Week 8 (Day 56) at predose, at 2 hours ±30 minutes; 4 hours ±30 minutes; 6 hours ±30 minutes; 8 hours ±30 minutes after morning dose | PK Analysis Set: all randomized participants who received at least one dose of omecamtiv mecarbil and had at least one evaluable omecamtiv mecarbil PK concentration. | hr*ng/mL | MEAN |
| SECONDARY | Change From Baseline at Week 16 in Systolic Ejection Time (SET) | Baseline, Week 16 (Day 112) | All participants who received at least one dose of study drug with observed data. The 4 active treatment arms include only those participants who had a minimum investigational product exposure period of 25 days. | msec | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to Week 20 (Day 140 + 3 days) | Safety Analysis Set: all participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg BID | Week 2 | 239 | Standard Deviation 106 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | Week 2 | 179 | Standard Deviation 77.1 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | Week 2 | 208 | Standard Deviation 61.6 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg BID | Week 4 | 222 | Standard Deviation 63.5 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | Week 4 | 196 | Standard Deviation 44 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | Week 4 | 209 | Standard Deviation 61.9 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg BID | Week 12 | 217 | Standard Deviation 66.1 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | Week 12 | 228 | Standard Deviation 56.9 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | Week 12 | 282 | Standard Deviation 120 | ng/mL |
| Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time | Omecamtiv Mecarbil 25 mg BID | Week 16 | 206 | Standard Deviation 84.5 | ng/mL |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo BID | 21 | |
| Overall Study | STARTED | Omecamtiv Mecarbil 25 mg BID | 21 | |
| Overall Study | STARTED | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 19 | |
| Overall Study | STARTED | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 20 | |
| Overall Study | COMPLETED | Placebo BID | 21 | |
| Overall Study | COMPLETED | Omecamtiv Mecarbil 25 mg BID | 20 | |
| Overall Study | COMPLETED | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 19 | |
| Overall Study | COMPLETED | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 20 | |
| Overall Study | NOT COMPLETED | Placebo BID | 0 | |
| Overall Study | NOT COMPLETED | Omecamtiv Mecarbil 25 mg BID | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events184
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo BID | 0 | 21 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Omecamtiv Mecarbil 25 mg BID | 2 | 21 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 0 | 19 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 0 | 20 | |
| other | Bradycardia | Cardiac disorders | Placebo BID | 0 | 21 | |
| other | Bradycardia | Cardiac disorders | Omecamtiv Mecarbil 25 mg BID | 0 | 21 | |
| other | Bradycardia | Cardiac disorders | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 1 | 19 | |
| other | Bradycardia | Cardiac disorders | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 0 | 20 | |
| other | Cardiac failure congestive | Cardiac disorders | Placebo BID | 0 | 21 | |
| other | Cardiac failure congestive | Cardiac disorders | Omecamtiv Mecarbil 25 mg BID | 0 | 21 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo BID | 0 | 21 |
| Total, all-cause mortality | Omecamtiv Mecarbil 25 mg BID | 1 | 21 |
| Total, all-cause mortality | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 0 | 19 |
| Total, all-cause mortality | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 0 | 20 |
| Total, other adverse events | Placebo BID | 10 | 21 |
| Total, other adverse events | Omecamtiv Mecarbil 25 mg BID | 8 | 21 |
| Total, other adverse events | Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose | 10 | 19 |
| Total, other adverse events | Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose | 11 | 20 |
| Total, serious adverse events | Placebo BID | 3 | 21 |
| Total, serious adverse events | Omecamtiv Mecarbil 25 mg BID | 4 | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02695420
GET https://conductscience.org/api/trials/v1/NCT02695420/results?page=2