Clinical trial
An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously…
NCT01819727 · BioMarin Pharmaceutical, Industry · Completed
Key facts
| NCT number | NCT01819727 |
|---|---|
| Title | An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165 |
| Official title | A Phase 3, Open-Label, Randomized, Multi-Center Study to Assess the Safety & Tolerability of an Induction, Titration, and Maintenance Dose Regimen of BMN 165 Self Administered by Adults With PKU Not Previously Treated With BMN 165 |
| Acronym | Prism301 |
| Lead sponsor | BioMarin Pharmaceutical, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Phenylketonuria |
| Intervention type | Drug |
| Interventions | BMN 165 |
| Enrollment | 261 |
| Start date | May 1, 2013 |
| Primary completion | Nov 25, 2015 |
| Completion | Nov 25, 2015 |
| First posted | Mar 28, 2013 |
| Last update posted | Feb 26, 2019 |
| Countries | United States |
At a glance
- 10–99 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: