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

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ClinicalTrials.gov Identifier: NCT02695420
Recruitment Status : Completed
First Posted : March 1, 2016
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
- 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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : May 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




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

  2. 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 :
  1. Systolic ejection time (SET) [ Time Frame: Week 16 ]
    Changes from baseline in Systolic Ejection Time (SET)


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



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
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.


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
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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
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02695420     History of Changes
Other Study ID Numbers: 20120227
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: January 2018
Keywords provided by Amgen:
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases