A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
NCT02351856
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- Discontinued treatment in the parent study for any reason other than study completion
or Sponsor termination of the study.
- Additional criteria exist.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Stanford, California
- Aurora, Colorado
- Baltimore, Maryland
- Boston, Massachusetts
- Columbus, Ohio
- Madison, Wisconsin
- Aurora, Colorado
- Baltimore, Maryland
- Boston, Massachusetts
- Madison, Wisconsin
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy | ||||||
Official Title ICMJE | An Open-label Rollover Study of ARRY-371797 in Patients With Symptomatic Genetic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | LMNA-Related Dilated Cardiomyopathy | ||||||
Intervention ICMJE | Drug: ARRY-371797, p38 inhibitor, oral
multiple dose, single schedule | ||||||
Study Arms ICMJE | Experimental: ARRY-371797
Intervention: Drug: ARRY-371797, p38 inhibitor, oral | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 8 | ||||||
Original Estimated Enrollment ICMJE | 12 | ||||||
Estimated Study Completion Date ICMJE | November 4, 2020 | ||||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02351856 | ||||||
Other Study ID Numbers ICMJE | ARRAY-797-001 C4411001 ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |