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

NCT03439514 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-01-09

Study results available
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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

DRUG

ARRY-371797 (PF-07265803)

400 mg twice daily (BID)

OTHER

Placebo

BID

Sponsors & Collaborators

Principal Investigators

  • Pfizer Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2022-10-13
Completion
2022-10-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439514 on ClinicalTrials.gov