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Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction

Trial Profile

Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Dec 2018

At a glance

  • Drugs MYK 491 (Primary)
  • Indications Dilated cardiomyopathy
  • Focus Adverse reactions; Proof of concept
  • Sponsors MyoKardia
  • Most Recent Events

    • 11 Dec 2018 Positive topline results published in a MyoKardia media release.
    • 30 Oct 2018 Study protocol was amended with addition of phase II multiple ascending part.Accordingly, study title, planned patient number from 12 to 56, design, treatment section and inclusion crietria was revised.
    • 30 Oct 2018 Planned number of patients changed from 12 to 56.
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