Status:
COMPLETED
Effect of Febuxostat on Blood Pressure
Lead Sponsor:
Takeda
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 hyperur...
Detailed Description
This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01496469
Start Date
February 1 2012
End Date
August 1 2014
Last Update
August 31 2015
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Foley, Alabama, United States
2
Buena Park, California, United States
3
Carmichael, California, United States
4
Fresno, California, United States