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Small Molecule

ARRY-371797 (PF-07265803) for Dilated Cardiomyopathy (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

REALM-DCM Trial Summary

This trial is testing a new drug for people with a heart condition caused by a mutation in the LMNA gene. The study will see if the drug is safe and effective, and if so, patients may be able to take it long-term.

Eligible Conditions

Dilated Cardiomyopathy
Lamin Gene Mutation

REALM-DCM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+9 more

REALM-DCM Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2 Open-label TreatmentExperimental Treatment1 Intervention

ARRY-371797 (PF-07265803) tablet orally

Group II: Part 1 Double-blind TreatmentExperimental Treatment2 Interventions

ARRY-371797 (PF-07265803) tablet orally OR matching placebo tablet orally

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,910,401 Total Patients Enrolled

Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer

22 Previous Clinical Trials

6,530 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Please could you tell me how many different sites are participating in this research?

"This study is looking for participants from 58 different medical centres, which are situated in locations such as Montreal, Atlanta and Tucson. You can help reduce the burden of travel by enrolling at the closest location to you."

Answered by AI

Is there a danger to taking ARRY-371797 (PF-07265803)?

"Given that this is a Phase 3 clinical trial with some efficacy data and multiple rounds of safety data, our team at Power estimates the safety of ARRY-371797 (PF-07265803) to be a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of ARRY-371797 (PF-07265803) in Patients With Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03439514.