Clinical trial
Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea…
NCT00345605 · Brendan Lee, Other · Completed
Key facts
| NCT number | NCT00345605 |
|---|---|
| Title | Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder |
| Official title | A Randomized, Double-Blind, Crossover Study of Sodium Phenylbutyrate and Low-Dose Arginine Compared to High-Dose Arginine Alone on Liver Function, Ureagenesis and Subsequent Nitric Oxide Production in Patients With Argininosuccinic Aciduria |
| Lead sponsor | Brendan Lee, Other |
| Collaborators | Office of Rare Diseases (ORD) NIH Rare Diseases Clinical Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Argininosuccinic Aciduria, Amino Acid Metabolism, Inborn Errors, Urea Cycle Disorders |
| Intervention type | Drug |
| Interventions | Sodium Phenylbutyrate, Arginine |
| Enrollment | 12 |
| Start date | Feb 1, 2008 |
| Primary completion | May 1, 2011 |
| Completion | Nov 1, 2012 |
| First posted | Jun 28, 2006 |
| Last update posted | Jan 31, 2018 |
| Countries | 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: