A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)
A Phase 3, Randomized, Multi-Center, Multi-National, Double-Blind Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once Daily Versus Twice Daily Dosing of Genz-112638 in Patients With Gaucher Disease Type 1 Who Have Demonstrated Clinical Stability on a Twice Daily Dose of Genz-112638
Sponsor: Genzyme, a Sanofi Company
Listed as NCT01074944, this PHASE3 trial focuses on Gaucher Disease and remains completed. Sponsored by Genzyme, a Sanofi Company, it has been updated 7 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jun 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Genzyme, a Sanofi Company
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Amsterdam, Netherlands , Athens, Greece , Beijing, China , Belgrade, Serbia , Belo Horizonte, Brazil , Bordeaux, France , Brasília, Brazil , Bron, France , Camperdown, Australia , Campinas, Brazil and 32 more locations