Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina
TerminatedPhase 2NCT01549977
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo as an add on to stable anti-anginal therapy, on the total exercise time of participants with Chronic Stable Angina.
Study details
- Official title
- A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Exercise Tolerance in Subjects With Chronic Stable Angina
- Conditions
- Interventions
- Drug: Febuxostat
- Drug: Placebo
- Sponsor
- Takeda
- Start date
- 2012-07
- Primary completion
- 2012-11
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 21
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative, signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The participant has an serum urate (sUA) ≥5.0 mg/dL. 4. The participant has a history of angina, defined as: 1. Minimum of 3-month history of stable angina (at least 2 episodes of chest pain or anginal equivalent in the past 30 days); AND 2. Receiving at least one chronic anti-ischemic medication(s), including beta blockers, calcium channel blockers and long acting nitrates (doses must be stable for at least 30 days prior to Screening \[Day -21\]); AND 3. Coronary artery disease, as defined by: * ≥50 % stenosis of ≥1 major coronary artery confirmed by angiography; OR * Documented prior myocardial infarction (MI) by enzymes/electrocardiogram (ECG) changes; OR * Documented myocardial imaging stress test; OR * Prior history of coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) greater than 3 months prior to Screening Day -21. 5. The participant has estimated glomerular filtration rate (eGFR) \>30 mL/min by Modification of Diet in Renal Disease (MDRD) at the Screening visit Day -21. 6. The participant has a normal/controlled blood pressure at Day 1/Randomization, as defined by the mean of three sitting blood pressures not exceeding 140/90. 7. The participant is male or female and aged 18 to 85 years, inclusive. 8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study. 9. Participant is on stable (30 days) medication doses prescribed for any underlying medical condition (ie; hypertension, angina) and will remain on stable doses throughout the study duration. 10. Participant is able to take, in an ongoing manner, nitroglycerine for anginal symptoms. 11. Symptom-limited exercise duration, during ETT at Day -14 and Day -7, on the modified Bruce Protocol. 12. Exercise duration for the two ETTs at Day -14 and Day -7 did not differ by more than 20% of the longer of the two times, and did not differ by more than 60 seconds. To be confirmed by the Core ECG Lab prior to the subject being randomized. 13. Def…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01549977