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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02695420
First received: February 25, 2016
Last updated: January 23, 2017
Last verified: January 2017
  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: 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
Study Start Date: April 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: February 25, 2016
Last Updated: January 23, 2017

Keywords provided by Amgen:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 28, 2017