Effect of Febuxostat Compared to Placebo on Exercise Tolerance in Participants With Chronic Stable Angina

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Angina

In brief

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.

Key facts

Study ID

NCT01549977

Run by

Takeda

People needed

1

Starts

2012-07-01

Expected to finish

2012-11-01

Last updated by the study team

2013-12-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• 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.
• The participant has an serum urate (sUA) ≥5.0 mg/dL.
• The participant has a history of angina, defined as:
• Minimum of 3-month history of stable angina (at least 2 episodes of chest pain or anginal equivalent in the past 30 days); AND
• 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
• 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.
• 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.
• 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.
• The participant is male or female and aged 18 to 85 years, inclusive.
• 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.
• 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.
• Participant is able to take, in an ongoing manner, nitroglycerine for anginal symptoms.
• Symptom-limited exercise duration, during ETT at Day -14 and Day -7, on the modified Bruce Protocol.
• 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.
• Definite ECG signs of ischemia during the ETT at both Day -14 and Day -7 (i.e., 1 additional mm of horizontal or down-sloping ST-segment depression beyond baseline and ≥1 mm below the isoelectric line) are present in at least one standard ECG lead during ETT. The Day -7 ≥1 mm ST-segment depression must be verified by the Core ECG Lab prior to participant being randomized.

You may not qualify if…

• The participant has received any investigational compound within 30 days prior to Screening Day -21.
• The participant has received allopurinol or febuxostat in a previous clinical study or as a therapeutic agent.
• The participant has gout or secondary hyperuricemia (e.g., due to myeloproliferative disorder, or organ transplant) or has experienced a gout flare.
• The participant has a history of xanthinuria.
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• The participant has a history of hypersensitivity or allergies to febuxostat or nitroglycerine.
• The participant has hemoglobin <10 g/L at Screening Day -21.
• The participant has a systolic blood pressure of less than 100 mmHg.
• The participant has a blood pressure of greater than 200/100 at any Screening or Run-in visit.
• The participant has a history or clinical manifestations of a significant medical condition that might affect his/her ability to complete the study.
• The participant has any of the following at any Screening or Run-in visit:
• Resting ST-segment depression ≥1 mm in any lead.
• Left bundle-branch block.
• New York Heart Association Class III or IV heart failure.
• Acute coronary syndrome or a coronary revascularization procedure within 3 months of Screening.
• Wolff-Parkinson-White syndrome.
• Pacemaker or implantable cardioverter defibrillator.
• Arrhythmias (i.e., SVT, atrial fibrillation/flutter, VT, or rate related bundle branch blocks).
• Left ventricular hypertrophy with repolarization abnormalities.
• The participant has a recent history (within the last 3 months) of myocardial infarction, heart failure, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• The participant has a contraindication for using nitrates (severe anemia, increased intracranial pressure, and those with a known sensitivity or hypersensitivity to nitroglycerin or its ingredients, or other nitrates or nitrites; concomitant use either regularly and/or intermittently, with phosphodiesterase type 5 (PDE5) inhibitors).
• The participant has unstable angina that:
• Occurs when the participant is at rest.
• Is prolonged, usually greater than 20 minutes.
• Occurs with increasing in intensity, duration, and/or frequency.

Where it is running

• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Irvine, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Tampa, Florida, United States
• Study site — Dunwoody, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Lexington, Kentucky, United States
• Study site — City of Saint Peters, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Lyndhurst, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tipton, Pennsylvania, United States
• Study site — San Antonio, Texas, United States
• Study site — Manassas, Virginia, United States
• Study site — Port Orchard, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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