Who is sponsoring NCT02695420?

NCT02695420 is sponsored by Cytokinetics.

What drugs are being tested in NCT02695420?

Interventions in NCT02695420: 25 mg Omecamtiv Mecarbil, Placebo, 37.5 mg Omecamtiv Mecarbil, 50 mg Omecamtiv Mecarbil.

What condition does NCT02695420 study?

NCT02695420 studies Heart Failure With Reduced Ejection Fraction.

Is NCT02695420 still recruiting?

NCT02695420 is currently completed. Last updated 27 July 2021.

Are results published for NCT02695420?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-27 · How we verify

NCT02695420

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

Completed Phase 2 Results posted Last updated 27 July 2021

What this trial tests

Phase 2 trial testing 25 mg Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction in 81 participants. Completed in 8 May 2017.

Timeline

14 April 2016

Primary endpoint
6 April 2017

8 May 2017

Quick facts

Lead sponsor	Cytokinetics
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	81
Start date	14 April 2016
Primary completion	6 April 2017
Estimated completion	8 May 2017
Sites	32 locations across Japan

Drugs / interventions tested

25 mg Omecamtiv Mecarbil — full drug profile →
Placebo
37.5 mg Omecamtiv Mecarbil — full drug profile →
50 mg Omecamtiv Mecarbil — full drug profile →

Conditions studied

Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →

Sponsor

Cytokinetics — full company profile →

Who can join

Adults 20 to 85, any sex, with Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time Primary · Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112)

Week 2

Group	Value	95% CI
Omecamtiv Mecarbil 25 mg BID	239	± 106
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	179	± 77.1
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	208	± 61.6

Week 4

Group	Value	95% CI
Omecamtiv Mecarbil 25 mg BID	222	± 63.5
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	196	± 44
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	209	± 61.9

Week 12

Group	Value	95% CI
Omecamtiv Mecarbil 25 mg BID	217	± 66.1
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	228	± 56.9
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	282	± 120

Week 16

Group	Value	95% CI
Omecamtiv Mecarbil 25 mg BID	206	± 84.5
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	244	± 67.7
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	292	± 118

PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8) Primary · 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

Group	Value	95% CI
Omecamtiv Mecarbil 25 mg BID	1850	± 563
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	1850	± 383
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	2360	± 465

Change From Baseline at Week 16 in Systolic Ejection Time (SET) Secondary · 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.

Group	Value	95% CI
Placebo BID	-1.7	± 4.7
Omecamtiv Mecarbil 25 mg BID	20.5	± 4.9
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	27.6	± 5.4
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	23.8	± 5.2

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · 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.

All TEAEs

Group	Value	95% CI
Placebo BID	14
Omecamtiv Mecarbil 25 mg BID	10
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	10
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	12

Grade >= 2 TEAEs

Group	Value	95% CI
Placebo BID	10
Omecamtiv Mecarbil 25 mg BID	6
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	6
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	7

Grade >= 3 TEAEs

Group	Value	95% CI
Placebo BID	3
Omecamtiv Mecarbil 25 mg BID	4
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	1
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	2

Grade >= 4 TEAEs

Group	Value	95% CI
Placebo BID	0
Omecamtiv Mecarbil 25 mg BID	1
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	0
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	0

Serious AEs

Group	Value	95% CI
Placebo BID	3
Omecamtiv Mecarbil 25 mg BID	4
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	1
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	3

TEAEs Leading to Withdrawal of Study Drug

Group	Value	95% CI
Placebo BID	0
Omecamtiv Mecarbil 25 mg BID	2
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	1
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	0

Fata Adverse Events

Group	Value	95% CI
Placebo BID	0
Omecamtiv Mecarbil 25 mg BID	1
Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose	0
Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to Week 20 (Day 140 + 3 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo BID

Serious: 3/21 (14%)

Deaths: 0/21

Omecamtiv Mecarbil 25 mg BID

Serious: 4/21 (19%)

Deaths: 1/21

Omecamtiv Mecarbil 25 mg to 37.5 mg BID Target Dose

Serious: 1/19 (5%)

Deaths: 0/19

Omecamtiv Mecarbil 25 mg to 50 mg BID Target Dose

Serious: 3/20 (15%)

Deaths: 0/20

Serious adverse events (11 terms)

Reaction	System	Placebo BID	Omecamtiv Mecarbil 25 mg BID	Omecamtiv Mecarbil 25 mg t…	Omecamtiv Mecarbil 25 mg t…
Angina pectoris	Cardiac disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Cardiac failure chronic	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Cardiac ventricular thrombosis	Cardiac disorders	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—
Ventricular fibrillation	Cardiac disorders	—	—	—	—
Vascular stent restenosis	General disorders	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—

Other adverse events (35 terms — click to expand)

Reaction	System	Placebo BID	Omecamtiv Mecarbil 25 mg BID	Omecamtiv Mecarbil 25 mg t…	Omecamtiv Mecarbil 25 mg t…
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—
Supraventricular extrasystoles	Cardiac disorders	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—
Tendon rupture	Injury, poisoning and procedural complications	—	—	—	—
Blood potassium increased	Investigations	—	—	—	—
Protein urine	Investigations	—	—	—	—
Troponin I increased	Investigations	—	—	—	—
Dyslipidaemia	Metabolism and nutrition disorders	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Renal impairment	Renal and urinary disorders	—	—	—	—
Gynaecomastia	Reproductive system and breast disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Toxic skin eruption	Skin and subcutaneous tissue disorders	—	—	—	—
Arteriosclerosis	Vascular disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Most-reported serious reactions: Angina pectoris, Cardiac failure, Cardiac failure chronic, Cardiac failure congestive, Cardiac ventricular thrombosis, Cardio-respiratory arrest, Ventricular fibrillation, Vascular stent restenosis.

Data from ClinicalTrials.gov NCT02695420 adverse events section.

Sponsor's own description

* To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction * To evaluate the safety and tolerability of oral omecamtiv mecarbil

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Heart Failure With Reduced Ejection Fraction

Currently open trials in the same condition.

NCT07465653 — A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction · Phase 1 · recruiting
NCT07465679 — A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treat · active not recruiting
NCT07275931 — Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study · NA · recruiting
NCT06942221 — Digital Solutions in Heart Therapy (DIGNITY) · NA · recruiting
NCT07087613 — Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG · recruiting

Other Cytokinetics trials

Trials by the same sponsor.

NCT05767346 — Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomat · Phase 3 · completed
NCT05924815 — Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval · Phase 1 · completed
NCT05877053 — A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants · Phase 1 · completed
NCT05662215 — A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants · Phase 1 · terminated
NCT05442775 — A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031) · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02695420 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cytokinetics
Last refreshed: 27 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02695420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing