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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

    perry.elliott@ucl.ac.uk

  • Sponsor organisation

    Array BioPharma Inc.

  • Eudract number

    2017-004310-25

  • Clinicaltrials.gov Identifier

    NCT03439514

  • 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