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Trial record 51 of 157 for:    Idiopathic Dilated Cardiomyopathy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02351856
Recruitment Status : Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : February 28, 2019
Information provided by (Responsible Party):
Array BioPharma

Brief Summary:
This is a rollover study designed to investigate the safety and effectiveness of investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and may, in the Investigator's opinion, derive benefit from continued treatment.

Condition or disease Intervention/treatment Phase
LMNA-Related Dilated Cardiomyopathy Drug: ARRY-371797, p38 inhibitor, oral Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2015
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: ARRY-371797 Drug: ARRY-371797, p38 inhibitor, oral
multiple dose, single schedule

Primary Outcome Measures :
  1. Assess the safety of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Assess the efficacy of study drug in terms of change in 6-minute walk test. [ Time Frame: 24 months ]
  2. Assess the efficacy of study drug in terms of left ventricular function. [ Time Frame: 24 months ]
  3. Assess the efficacy of study drug in terms of right ventricular function. [ Time Frame: 24 months ]
  4. Assess the efficacy of the study drug in terms of quality of life. [ Time Frame: 24 months ]
  5. Characterize the pharmacokinetics (PK) of study drug and metabolites in terms of plasma concentration-time profiles and model-based PK parameters. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02351856

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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Wisconsin
Meriter Wisconsin Heart
Madison, Wisconsin, United States, 53713
Sponsors and Collaborators
Array BioPharma

Additional Information:
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Responsible Party: Array BioPharma Identifier: NCT02351856     History of Changes
Other Study ID Numbers: ARRAY-797-001
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by Array BioPharma:
Additional relevant MeSH terms:
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Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases