Clinical Trial: Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Multi-Center, Open-Label, Ascending Dose Study on the Efficacy, Safety and Tolerability of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure With
Brief Summary: The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
Detailed Summary:
Sponsor: Heart Metabolics Limited
Current Primary Outcome: Change from baseline of VO2MAX [ Time Frame: end of Period 2 (Week 16) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline of VO2MAX [ Time Frame: end of Period 1 (Week 8) ]
- Change from baseline of VO2MAX [ Time Frame: end of Period 1 (Week 8) compared to end of Period 2 (Week 16) ]
- Change from baseline in the six-minute walk test [ Time Frame: end of Period 1 (Week 8) ]
- Change from baseline in the six-minute walk test [ Time Frame: end of Period 2 (Week 16) ]
- Change from baseline in the six-minute walk test [ Time Frame: end of Period 1 (Week 8) compared to end of Period 2 (Week 16) ]
- Safety measures to include assessments of adverse events, vital signs, ECGs, and laboratory assay results [ Time Frame: during Period 1 (Weeks 1-8) compared to during Period 2 (Weeks 9-16) ]
Original Secondary Outcome: Same as current
Information By: Heart Metabolics Limited
Dates:
Date Received: August 8, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: February 16, 2017
Last Verified: February 2017
