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

NCT01549977 | Terminated Phase 2 Results DMC

• 2 other identifiers: TMX-67_207U1111-1125-1278
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Angina

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12

  The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.

  Baseline and Week 12

Secondary Outcomes (4)

• Change From Baseline in Time to Onset of Angina During ETT at Week 12

  Baseline and Week 12

• Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12

  Baseline and Week 12

• Change From Baseline in Maximum ST-segment Depression During ETT at Week 12

  Baseline and Week 12

• Percentage of Participants Stopping ETT Due to Angina at Week 12

  Week 12

Study Arms (2)

Febuxostat 80 mg

EXPERIMENTAL

Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.

Drug: Febuxostat

Placebo

PLACEBO COMPARATOR

Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.

Drug: Placebo

Interventions

Febuxostat DRUG

Febuxostat tablets

Also known as: TMX-67, Uloric

Febuxostat 80 mg

Placebo DRUG

Febuxostat placebo-matching tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (21)

Unknown Facility

Carmichael, California, United States

Location

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

Irvine, California, United States

Location

Unknown Facility

Paramount, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Dunwoody, Georgia, United States

Location

Unknown Facility

Suwanee, Georgia, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

City of Saint Peters, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Salisbury, North Carolina, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Lyndhurst, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Tipton, Pennsylvania, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Manassas, Virginia, United States

Location

Unknown Facility

Port Orchard, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Links

• Uloric Package Insert

MeSH Terms

Conditions

Angina Pectoris

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 20, 2013
• Results First Posted: December 20, 2013

Record last verified: 2013-10

Locations

US (21)