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NCT00551200 · ClinicalTrials.gov registry record · Phase 2
Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders
A Phase 2 study of Urea Cycle Disorders, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT00551200: Completed Phase 2 study of Urea Cycle Disorders, sponsored by Amgen.
NCT00551200 is a Phase 2 study of Urea Cycle Disorders that has completed, run by Amgen. The registered enrollment target is 14 participants, below the 393-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00551200, a Phase 2 study of Urea Cycle Disorders, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.
Primary Outcome
Data were collected at pre-first dose and at 30 minutes and 1, 2, 4, 5, 6, 8, 10, 12, and 24 hours post first dose.
Conditions Studied
Interventions
- DRUG HPN-100
- DRUG BUPHENYL®
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00551200 record still lists
NCT00551200 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 393-participant average among 4 other Urea Cycle Disorders trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Urea Cycle Disorders appearing as the primary indexed condition, and to 2 interventions - of which HPN-100 is the first listed.
NCT00551200 reports a single indexed study location in Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT00551200 about?
NCT00551200 is a clinical study titled "Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders". The purpose of this study is to determine whether HPN-100 is safe and tolerable in subjects with Urea Cycle Disorders.
What is the current status of trial NCT00551200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2007-10. Estimated completion is 2008-12.
What conditions does trial NCT00551200 study?
This clinical trial studies the following conditions: Urea Cycle Disorders.
What interventions are being tested in trial NCT00551200?
The interventions under investigation include: HPN-100 (DRUG), BUPHENYL® (DRUG).
Who is sponsoring clinical trial NCT00551200?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00551200 being conducted?
This trial has 2 study locations across Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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