Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01101035 · ClinicalTrials.gov registry record · Phase 3
Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,198
- Enrollment target
NCT01101035: Completed Phase 3 study, sponsored by Takeda.
NCT01101035 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 6,198 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (703% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01101035, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,198 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
Primary Outcome
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Interventions
- DRUG Allopurinol
- DRUG Febuxostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,198 participants |
| Start Date | 2010-04-23 |
| Est. Completion | 2017-07-18 |
| Phase | Phase 3 |
What the finished NCT01101035 record still lists
NCT01101035 is an interventional study that assigns participants to a tested intervention. Its 6,198 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (703% higher).
The record links to 0 conditions, and to 2 interventions - of which Allopurinol is the first listed.
NCT01101035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01101035 about?
NCT01101035 is a clinical study titled "Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)". The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).
What is the current status of trial NCT01101035?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,198 participants. The study started on 2010-04-23. Estimated completion is 2017-07-18.
What interventions are being tested in trial NCT01101035?
The interventions under investigation include: Allopurinol (DRUG), Febuxostat (DRUG).
Who is sponsoring clinical trial NCT01101035?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01101035's enrollment target sits among peer trials
6,198 35th of 2000 higher than 1,966 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT07049861 · 6,200 participants · NA
Advancing Biopsychosocial Care Training Initiative
- NCT04774159 · 6,150 participants · Phase 3
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
- NCT06304168 · 6,150 participants
Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
- NCT03960099 · 6,250 participants · NA
Pictographs for Preventing Wrong-Patient Errors in NICUs
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI