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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 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 6,198 participants.

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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).

Interventions

  • DRUG Allopurinol
  • DRUG Febuxostat

Trial Details

FieldValue
Enrollment Target 6,198 participants
Start Date 2010-04-23
Est. Completion 2017-07-18
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT01101035

The ClinicalTrials.gov registry entry for NCT01101035 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 6,198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Allopurinol is the first listed.

NCT01101035 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.