Effect of Febuxostat on Blood Pressure

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo on lowering ambulatory 24-hour mean blood pressure of participants with hypertension and hyperuricemia (not associated with gout).

Key facts

Study ID

NCT01496469

Run by

Takeda

People needed

121

Starts

2012-02-01

Expected to finish

2014-08-01

Last updated by the study team

2015-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has documented hypertension, defined as average clinic systolic blood pressure (SBP) of ≥145 mm Hg and ≤165 mm Hg or average clinic diastolic blood pressure (DBP) of ≥90 mm Hg and ≤105 mm Hg at the Day -21 Screening Visit; the average BP measurement at two of the three Placebo Run-in Visits (Day -14, Day -7 and Day -1) must also meet the above criteria for hypertension.
• The participant has a serum uric acid (sUA) level ≥7.0 mg/dL not associated with gout, at the Day -21 Screening Visit.
• The participant has a 24-hour mean ambulatory SBP of ≥130 mm Hg and < 165 mm Hg at the Baseline (Day 1) Visit.
• At the initial Screening Visit (Day -21), the maximum number of antihypertensive medications the participant is taking is ≤ 2 (fixed-dose combination medications are considered 2 medications, including diuretics), and the participant has been on a stable dose of this medication for at least1 month prior to start of the initial Screening Visit (Day -21).
• The participant is male and at least 18 years of age, or a female who is:
• Surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation), OR
• Postmenopausal (defined as at least 1 year since last regular menses with an follicle-stimulating hormone (FSH) >40 IU/L, or at least 5 years since last regular menses), OR
• On hormone replacement therapy and ≥ 55 years of age.
• 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.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

You may not qualify if…

• The participant has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening Visit.
• The participant has received febuxostat or any urate-lowering therapy (ULT) in a previous clinical study or as a therapeutic agent.
• The participant has gout, history of gout, or gout flares.
• The participant has secondary hyperuricemia (HPU) (e.g., due to myeloproliferative disorder, or organ transplant).
• The participant has known secondary hypertension of any etiology (e.g., renovascular disease, primary hyperaldosteronism, Cushing syndrome).
• The participant has a history, within the 6 months prior to screening, of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention.
• The participant has an irregular cardiac rhythm (e.g., atrial fibrillation, multifocal premature atrial contractions) which leads to difficulty with interpretation of ambulatory blood pressure monitoring (ABPM).
• The participant has a history of congestive heart failure, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• The participant has type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin [HbA1c] >8.0%) at Screening.
• The participant has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• The participant has an average clinic SBP >165 mm Hg or DBP >105 mm Hg at 1 or more visits during the Placebo Run-in Period.
• The participant's average clinic SBP or DBP measurement that increases or decreases by >10 mm Hg between Placebo Run-in visits (Day -14 to Day -7, or Day -7 to Day -1, or Day -14 to Day -1).
• 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 an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 times the upper limit of normal (ULN).
• The participant has a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol.
• The participant has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming >14 alcoholic drinks per week.
• The participant has a known hypersensitivity or allergies to febuxostat or any components of the formulations of this compound.
• The participant is taking or expected to take a medication as described in the excluded medication section.
• The participant has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin.
• The participant's estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73m3, where eGFR is calculated by the Central Laboratory using the Modification of Diet in Renal Disease (MDRD) formula at the Day -21 Screening Visit.
• The participant is noncompliant (<80% or >120%) with study medication during Placebo Run-In Period.
• The participant has an upper arm circumference less than 24 cm or greater than 42 cm.
• The participant's work shift includes any hour between 11 PM (2300) to 7 AM (0700).
• The participant has a baseline 24-hour ABPM reading of insufficient quality (as described in Appendix F of the protocol).

Where it is running

• Study site — Foley, Alabama, United States
• Study site — Buena Park, California, United States
• Study site — Carmichael, California, United States
• Study site — Fresno, California, United States
• Study site — Irvine, California, United States
• Study site — Lomita, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Wildomar, California, United States
• Study site — Milford, Connecticut, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Dunwoody, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Avon, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Biddeford, Maine, United States
• Study site — City of Saint Peters, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Henderson, Nevada, United States

Full record on ClinicalTrials.gov

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