ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
NCT ID: NCT02319005
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2014-12-31
2017-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Revusiran (ALN-TTRSC)
administered by subcutaneous (SC) injection
Revusiran (ALN-TTRSC)
Sterile Normal Saline (0.9% NaCl)
administered by subcutaneous (SC) injection
Sterile Normal Saline (0.9% NaCl)
Interventions
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Revusiran (ALN-TTRSC)
Sterile Normal Saline (0.9% NaCl)
Eligibility Criteria
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Inclusion Criteria
* Amyloid deposits in cardiac or non-cardiac tissue
* Medical history of heart failure
* Evidence of cardiac involvement by echocardiogram
Exclusion Criteria
* Has known peripheral vascular disease affecting ambulation
* Has a Polyneuropathy Disability score \>2
* Has a New York Heart Association (NYHA) classification of IV
18 Years
90 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jared Gollob, MD
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Bakersfield, California, United States
Clinical Trial Site
Beverly Hills, California, United States
Clinical Trial Site
La Mesa, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Newark, New Jersey, United States
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New York, New York, United States
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Rosedale, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Anderlecht, , Belgium
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Hasselt, , Belgium
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Roeselare, , Belgium
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Toronto, , Canada
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Bordeaux, Aquitaine, France
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Créteil, , France
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Marseille, , France
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Paris, , France
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Heidelberg, , Germany
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Münster, , Germany
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Bologna, , Italy
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Messina, , Italy
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Pavia, , Italy
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Umeå, , Sweden
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Croydon, England, United Kingdom
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London, England, United Kingdom
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Tooting, , United Kingdom
Countries
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References
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Judge DP, Kristen AV, Grogan M, Maurer MS, Falk RH, Hanna M, Gillmore J, Garg P, Vaishnaw AK, Harrop J, Powell C, Karsten V, Zhang X, Sweetser MT, Vest J, Hawkins PN. Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR). Cardiovasc Drugs Ther. 2020 Jun;34(3):357-370. doi: 10.1007/s10557-019-06919-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALN-TTRSC-004
Identifier Type: -
Identifier Source: org_study_id
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