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

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum up to 212.28 weeks (maximum exposure was 208 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial tests ARRY-371797, a medication, in patients with a specific heart condition caused by an LMNA gene mutation. The drug aims to improve heart function in these patients.

Eligible Conditions

Dilated Cardiomyopathy
Lamin Gene Mutation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum up to 212.28 weeks (maximum exposure was 208 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum up to 212.28 weeks (maximum exposure was 208 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum up to 212.28 weeks (maximum exposure was 208 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Six-Minute Walk Test (6 MWT) at Week 24

Secondary study objectives

Change From Baseline in 6 MWT at Weeks 4 and 12

Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation (PL) and Total Symptom Score (TSS) Domain Scores at Weeks 12 and 24

Change From Baseline in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Weeks 4, 12, and 24

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