Clinical trial
A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase…
NCT00158600 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00158600 |
|---|---|
| Title | A Placebo-Controlled Study of Safety and Effectiveness of Myozyme (Alglucosidase Alfa) in Patients With Late-Onset Pompe Disease |
| Official title | Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy and Pharmacokinetics of Myozyme in Patients With Late-Onset Pompe Disease. |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Pompe Disease (Late-onset), Glycogen Storage Disease Type II (GSD-II), Acid Maltase Deficiency Disease, Glycogenosis 2 |
| Intervention type | Biological, Drug |
| Interventions | alglucosidase alfa, Placebo |
| Enrollment | 90 |
| Start date | Sep 1, 2005 |
| Primary completion | Sep 1, 2007 |
| Completion | Sep 1, 2007 |
| First posted | Sep 12, 2005 |
| Last update posted | Apr 28, 2015 |
| Countries | France, Netherlands, United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: