Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01391325 · ClinicalTrials.gov registry record · Phase 4
Allopurinol Outcome Study
A Phase 4 study, sponsored by Ardea Biosciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,735
- Enrollment target
NCT01391325: Completed Phase 4 study, sponsored by Ardea Biosciences.
NCT01391325 is a Phase 4 study that has completed, run by Ardea Biosciences. The registered enrollment target is 1,735 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01391325, a Phase 4 study, has completed, sponsored by Ardea Biosciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,735 participants
- Enrollment target
Study Summary
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the Investigator, to achieve an optimal, medically appropriate dose for each patient.
Primary Outcome
Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.
Interventions
- DRUG Allopurinol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,735 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
What the finished NCT01391325 record still lists
NCT01391325 is an interventional study that assigns participants to a tested intervention. Its 1,735 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (235% higher).
The record links to 0 conditions, and to 1 intervention - of which Allopurinol is the first listed.
NCT01391325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01391325 about?
NCT01391325 is a clinical study titled "Allopurinol Outcome Study". This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months. Allopurinol will be dosed according to the local product label, at the discretion of the I...
What is the current status of trial NCT01391325?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,735 participants. The study started on 2011-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01391325?
The interventions under investigation include: Allopurinol (DRUG).
Who is sponsoring clinical trial NCT01391325?
This trial is sponsored by Ardea Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01391325's enrollment target sits among peer trials
1,735 45th of 2000 higher than 1,956 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04712656 · 1,739 participants
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
- NCT06413420 · 1,731 participants
SUNOSI® (Solriamfetol) Pregnancy Registry
- NCT06898034 · 1,725 participants
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
- NCT05934487 · 1,750 participants · NA
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia