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Trial record 5 of 9 for:    omecamtiv

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02695420
First Posted: March 1, 2016
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
- 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

Condition Intervention Phase
Heart Failure With Reduced Ejection Fraction Drug: 25 mg Omecamtiv Mecarbil Drug: Placebo Drug: 37.5 mg Omecamtiv Mecarbil Drug: 50 mg Omecamtiv Mecarbil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Pharmacokinetics (Cpredose) [ Time Frame: 16 weeks ]
    Omecamtiv mecarbil concentration before morning dose at weeks 2, 4, 12, and 16

  • Pharmacokinetics (AUC) [ Time Frame: Week 8 ]
    Omecamtiv mecarbil concentration area under the curve until 8 hours after morning dose at week 8


Secondary Outcome Measures:
  • Systolic ejection time (SET) [ Time Frame: Week 16 ]
    Changes from baseline in Systolic Ejection Time (SET)


Other Outcome Measures:
  • Subject Incidence of Adverse Events [ Time Frame: 20 weeks ]
    Subject incidence of adverse events from baseline to week 20 (end of study)


Enrollment: 81
Actual Study Start Date: April 14, 2016
Study Completion Date: May 8, 2017
Primary Completion Date: April 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 mg Omecamtiv Mecarbil
25 mg Omecamtiv Mecarbil BID
Drug: 25 mg Omecamtiv Mecarbil
Drug: Omecamtiv Mecarbil Subjects will receive Omecamtiv Mecarbil 25 mg BID
Placebo Comparator: Placebo
Placebo BID
Drug: Placebo
Drug: n/a Subjects will receive Placebo BID
Experimental: 37. 5 mg Omecamtiv Mecarbil
37.5 mg Omecamtiv Mecarbil BID Target Dose
Drug: 37.5 mg Omecamtiv Mecarbil
Drug: Omecamtiv Mecarbil Subjects will receive Omecamtiv Mecarbil 25 mg BID up to week 4 or week 8 and 25 mg or 37.5 mg BID after week 4 or week 8, based on week 2 PK
Experimental: 50 mg Omecamtiv Mecarbil
50 mg Omecamtiv Mecarbil BID Target Dose
Drug: 50 mg Omecamtiv Mecarbil
Drug: Omecamtiv Mecarbil Subjects will receive Omecamtiv Mecarbil 25 mg BID up to week 4 or week 8 and 25 mg or 50 mg BID after week 4 or week 8, based on week 2 PK

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: -Japanese male or female ≥ 20 years and ≤ 85 years of age -History of chronic stable HF with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening -Reated for HF with optimal pharmacological therapy -Left ventricular ejection fraction ≤ 40% at screening.

Exclusion Criteria: -Severe uncorrected valvular heart disease -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, or HR > 110 beats per minute (bpm) or HR < 50 bpm -Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 -TBL ≥ 2x ULN, or ALT or AST ≥ 3x ULN -Other Exclusion Criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695420


Locations
Japan
Research Site
Kasugai-shi, Aichi, Japan, 486-8510
Research Site
Kasugai-shi, Aichi, Japan, 487-0016
Research Site
Nagoya-shi, Aichi, Japan, 454-8509
Research Site
Asahi-shi, Chiba, Japan, 289-2511
Research Site
Chiba-shi, Chiba, Japan, 260-8606
Research Site
Imabari-shi, Ehime, Japan, 799-1592
Research Site
Chikushino-shi, Fukuoka, Japan, 818-8516
Research Site
Fukuoka-shi, Fukuoka, Japan, 814-0180
Research Site
Fukuoka-shi, Fukuoka, Japan, 815-8588
Research Site
Hakodate-shi, Hokkaido, Japan, 041-8512
Research Site
Sapporo, Hokkaido, Japan, 060-8648
Research Site
Amagasaki-shi, Hyogo, Japan, 660-8550
Research Site
Kawanishi-shi, Hyogo, Japan, 666-0125
Research Site
Takarazuka-shi, Hyogo, Japan, 665-0873
Research Site
Kanazawa-shi, Ishikawa, Japan, 920-8650
Research Site
Nankoku-shi, Kochi, Japan, 783-8505
Research Site
Oita-shi, Oita, Japan, 870-0192
Research Site
Okayama-shi, Okayama, Japan, 702-8055
Research Site
Kishiwada-shi, Osaka, Japan, 596-8522
Research Site
Osaka-shi, Osaka, Japan, 532-0003
Research Site
Osaka-shi, Osaka, Japan, 550-0012
Research Site
Osaka-shi, Osaka, Japan, 559-0012
Research Site
Suita-shi, Osaka, Japan, 565-0871
Research Site
Saga-shi, Saga, Japan, 840-8571
Research Site
Saitama-shi, Saitama, Japan, 330-8503
Research Site
Wako-shi, Saitama, Japan, 351-0102
Research Site
Sunto-gun, Shizuoka, Japan, 411-8611
Research Site
Chiyoda-ku, Tokyo, Japan, 101-8309
Research Site
Itabashi-ku, Tokyo, Japan, 173-0015
Research Site
Itabashi-ku, Tokyo, Japan, 173-8610
Research Site
Meguro-ku, Tokyo, Japan, 152-8902
Research Site
Shinagawa-ku, Tokyo, Japan, 141-0001
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02695420     History of Changes
Other Study ID Numbers: 20120227
First Submitted: February 25, 2016
First Posted: March 1, 2016
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Amgen:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases