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| ID | Type | Description | Link |
|---|---|---|---|
| C4411004 | Other Identifier | Pfizer |
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This is a Phase 2 pilot study, involving a 48-week treatment period, designed to test the effectiveness of investigational study drug ARRY-371797 in treating patients with symptomatic genetic dilated cardiomyopathy due to a lamin A/C gene mutation, and to further evaluate the drug's safety. Approximately 12 patients from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-371797 (Dose 1) | Experimental |
| |
| ARRY-371797 (Dose 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-371797, p38 inhibitor; oral | Drug | multiple dose, single schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug in terms of change from Baseline in 6-minute walk test. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of study drug in terms of left ventricular function. | 48 weeks | |
| Assess the efficacy of study drug in terms of right ventricular function. | 48 weeks | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| University of Colorado School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979608 | Derived | Garcia-Pavia P, Palomares JFR, Sinagra G, Barriales-Villa R, Lakdawala NK, Gottlieb RL, Goldberg RI, Elliott P, Lee P, Li H, Angeli FS, Judge DP, MacRae CA; REALM-DCM Investigators. REALM-DCM: A Phase 3, Multinational, Randomized, Placebo-Controlled Trial of ARRY-371797 in Patients With Symptomatic LMNA-Related Dilated Cardiomyopathy. Circ Heart Fail. 2024 Jul;17(7):e011548. doi: 10.1161/CIRCHEARTFAILURE.123.011548. Epub 2024 Jul 9. | |
| 37010012 |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D000083083 | Laminopathies |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| C000592910 | ARRY-371797 |
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| Assess the safety of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. |
| 48 weeks |
| Characterize the pharmacokinetics (PK) of study drug and metabolites in terms of plasma concentration-time profiles and model-based PK parameters. | 48 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Meriter Wisconsin Heart | Madison | Wisconsin | 53713 | United States |
| Derived |
| Judge DP, Taylor MR, Li H, Oliver C, Angeli FS, Lee PA, MacRae CA. Long-term effectiveness of ARRY-371797 in people with dilated cardiomyopathy and a faulty LMNA gene: a plain language summary. Future Cardiol. 2023 Mar;19(3):117-126. doi: 10.2217/fca-2022-0125. Epub 2023 Apr 3. |
| 36718638 | Derived | MacRae CA, Taylor MR, Mestroni L, Moses J, Ashley EA, Wheeler MT, Lakdawala NK, Hershberger RE, Sandor V, Saunders ME, Oliver C, Lee PA, Judge DP. Plain Language Summary of Publication of the safety and efficacy of ARRY-371797 in people with dilated cardiomyopathy and a faulty LMNA gene. Future Cardiol. 2023 Feb;19(2):55-63. doi: 10.2217/fca-2022-0099. Epub 2023 Jan 31. |
| 36515663 | Derived | MacRae CA, Taylor MRG, Mestroni L, Moses J, Ashley EA, Wheeler MT, Lakdawala NK, Hershberger RE, Sandor V, Saunders ME, Oliver C, Lee PA, Judge DP. Efficacy and Safety of ARRY-371797 in LMNA-Related Dilated Cardiomyopathy: A Phase 2 Study. Circ Genom Precis Med. 2023 Feb;16(1):e003730. doi: 10.1161/CIRCGEN.122.003730. Epub 2022 Dec 14. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |