A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy

Plain-language summary

This study examined continued treatment with ARRY-371797 in patients with dilated cardiomyopathy caused by LMNA gene mutations, a condition in which the heart muscle becomes enlarged and weakened. It enrolled patients who had previously received ARRY-371797 in earlier studies and who might benefit from ongoing treatment. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Pfizer

Intervention

ARRY-371797, p38 inhibitor, oral

Start date

2/2/2015

Estimated completion

12/21/2020

Countries

United States

Related genes

Locations

• Aurora, United States
• Baltimore, United States
• Boston, United States
• Madison, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key Inclusion Criteria:

* Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to LMNA mutations in a clinical study sponsored by Array BioPharma.
* May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.
* Additional criteria exist.

Key Exclusion Criteria:

* Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
* Additional criteria exist.