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NCT01074944 · ClinicalTrials.gov registry record · Phase 3
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
NCT01074944 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 170 participants.
The verdict
NCT01074944, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 170 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). The secondary objective was to evaluate the pharmacokinetics (PK) of Genz-99067 when eliglustat tartrate (Genz-112638) was administered QD and BID in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638).
Interventions
- DRUG Eliglustat tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01074944
The ClinicalTrials.gov registry entry for NCT01074944 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eliglustat tartrate is the first listed.
NCT01074944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01074944 about?
NCT01074944 is a clinical study titled "A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)". The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated clinical stability on BID dosing of eliglustat tartrate (Genz-112638). ...
What is the current status of trial NCT01074944?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2010-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01074944?
The interventions under investigation include: Eliglustat tartrate (DRUG).
Who is sponsoring clinical trial NCT01074944?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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