NCT03439514

A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation (REALM-DCM)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled study in patients with dilated cardiomyopathy (DCM) due to a mutation of the gene encoding the lamin A/C protein (LMNA). The study will further evaluate a dose level of study drug (ARRY-371797) that has shown preliminary efficacy and safety in this patient population. After the primary analysis has been performed, eligible patients may receive open-label treatment with ARRY-371797.

Conditions

• Dilated Cardiomyopathy
• Lamin A/C Gene Mutation

Interventions

Type	Name	Description
DRUG	ARRY-371797 (PF-07265803)	400 mg twice daily (BID)
OTHER	Placebo	BID

Timeline

• Start date: 2018-04-17
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2018-02-20
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

107 sites across 10 countries: United States, Argentina, Belgium, Canada, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study