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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 currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02695420
First received: February 25, 2016
Last updated: November 2, 2016
Last verified: October 2016
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Omecamtiv mecarbil concentration before morning dose at weeks 2, 4, 12, and 16

  • Pharmacokinetics (AUC) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes from baseline in Systolic Ejection Time (SET)


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


Estimated Enrollment: 80
Study Start Date: April 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02695420

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
Japan
Research Site Recruiting
Kasugai-shi, Aichi, Japan, 486-8510
Research Site Recruiting
Kasugai-shi, Aichi, Japan, 487-0016
Research Site Recruiting
Nagoya-shi, Aichi, Japan, 454-8509
Research Site Recruiting
Asahi-shi, Chiba, Japan, 289-2511
Research Site Recruiting
Chiba-shi, Chiba, Japan, 260-8606
Research Site Recruiting
Imabari-shi, Ehime, Japan, 799-1592
Research Site Recruiting
Chikushino-shi, Fukuoka, Japan, 818-8516
Research Site Recruiting
Fukuoka-shi, Fukuoka, Japan, 814-0180
Research Site Recruiting
Fukuoka-shi, Fukuoka, Japan, 815-8588
Research Site Recruiting
Hakodate-shi, Hokkaido, Japan, 041-8512
Research Site Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Research Site Recruiting
Amagasaki-shi, Hyogo, Japan, 660-8550
Research Site Recruiting
Kawanishi-shi, Hyogo, Japan, 666-0125
Research Site Recruiting
Takarazuka-shi, Hyogo, Japan, 665-0873
Research Site Recruiting
Kanazawa-shi, Ishikawa, Japan, 920-8650
Research Site Recruiting
Nankoku-shi, Kochi, Japan, 783-8505
Research Site Recruiting
Oita-shi, Oita, Japan, 870-0192
Research Site Recruiting
Okayama-shi, Okayama, Japan, 702-8055
Research Site Recruiting
Kishiwada-shi, Osaka, Japan, 596-8522
Research Site Recruiting
Osaka-shi, Osaka, Japan, 532-0003
Research Site Recruiting
Osaka-shi, Osaka, Japan, 550-0012
Research Site Recruiting
Osaka-shi, Osaka, Japan, 559-0012
Research Site Recruiting
Suita-shi, Osaka, Japan, 565-0871
Research Site Recruiting
Saga-shi, Saga, Japan, 840-8571
Research Site Recruiting
Saitama-shi, Saitama, Japan, 330-8503
Research Site Recruiting
Wako-shi, Saitama, Japan, 351-0102
Research Site Recruiting
Sunto-gun, Shizuoka, Japan, 411-8611
Research Site Recruiting
Chiyoda-ku, Tokyo, Japan, 101-8309
Research Site Recruiting
Itabashi-ku, Tokyo, Japan, 173-0015
Research Site Recruiting
Itabashi-ku, Tokyo, Japan, 173-8610
Research Site Recruiting
Meguro-ku, Tokyo, Japan, 152-8902
Research Site Recruiting
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: November 2, 2016
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Device Agency (PMDA)

Keywords provided by Amgen:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016