Phase 3 Study of ARRY-371797 in Lamin A/C Gene Mutation-related DCM
Research type
Research Study
Full title
A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
IRAS ID
254544
Contact name
Perry Elliott
Contact email
Sponsor organisation
Array BioPharma Inc.
Eudract number
2017-004310-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 15 days
Research summary
This is a phase 3, Multinational, Randomised, Placebo-controlled Study of ARRY-371797 (study drug) in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation. The main purpose of the research study is to evaluate the
effect of the study drug ARRY-371797 on the patients’ ability to walk over a 6-minute period (as measured by the 6-minute walk test) compared to placebo in at least 120 patients with symptomatic New York Heart Association (NYHA)Class II/III/IV dilated cardiomyopathy (DCM) secondary to LMNA mutations. NYHA functional Class IV patients (up to approximately 40) will also be enrolled at a 1:1 randomisation and will be assessed for overall safety and time from randomisation to heart failure related hospitalisation or death.
The study will be conducted in 2 parts: a randomised, double-blind treatment period for at least 24 weeks, followed by an ARRY-371797 open-label treatment period where patients will be eligible to receive 400 mg ARRY-371797 (study drug) taken twice a day. Study procedures include medical history, physical examination, vital signs, blood and urine sample collection, ECG, Arrhythmia assessment, and 6 minute walk test, Echocardiogram.
Array BioPharma Inc. is sponsoring this trial and it is expected that approximately 160 patients with genetic dilated cardiomyopathy, who are 18 years and older, will participate in this study in the UK Argentina, Belgium, Canada, France, Germany, Italy, Mexico, Netherlands, Norway, Spain and the USA with an expected 12 patients from the UK.REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1798
Date of REC Opinion
14 Dec 2018
REC opinion
Further Information Favourable Opinion