Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart Failure

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

Not specified

Primary Completion Date

July 31, 2017

Conditions
Hypertrophic Cardiomyopathy
Interventions
DRUG

Perhexiline

perhexiline maleate, oral, 25mg or 100mg tablets Whenever initiating PHM therapy, subjects will receive a loading regimen of PHM as indicated in in the Heart Metabolics Dose Justification document. Drug levels will be measured first on Day 4 +/- 1 day, with an initial dose adjustment performed on Day 7 +/- 1 day, as needed. The next sampling will occur on Day 21 +/- 1 day for potential dose adjustment, as advised by the DCC, on or about Day 24. Subsequent dosing will be monitored and advised by a Dose Control Center

DRUG

Placebo

Sponsors
All Listed Sponsors
lead

Heart Metabolics Limited

INDUSTRY