NCT01496469已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension
Takeda0 个研究点目标入组 121 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
研究概览
简要总结
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).
详细描述
This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Febuxostat 80 mg QD
Experimental
Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks.
干预措施: Febuxostat (Drug)
Placebo QD
Placebo Comparator
Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
时间窗: Baseline and Week 6
The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
次要结局
- Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6(Baseline and Week 6)
- Change From Baseline in Serum Urate Levels at Week 6(Baseline and Week 6)
研究者
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