PER-026-08已完成未知
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co-administered With Amlodipine 5 mg in Subjects With Essential Hypertension
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
- 性别
- All
入选标准
- •The patient has essential arterial hypertension (defined as a PAS nadir measured in the clinic in a sitting position between 160 and 190 mm Hg including Day -1 [day prior to randomization]) and an average SBP of 24 hours> 140 mm Hg and <180 mm Hg on Day 1 (day of randomization).
- •The patient is male or female 18 years of age or older.
- •The patient has the ability to understand the requirements of the protocol and can meet them.
- •The patient or his / her legal representative signs a written informed consent form before initiating any study procedure.
- •Female patients of childbearing age and sexually active should agree to use an adequate contraceptive method (as indicated on the informed consent form) from the selection period and throughout the study.
- •The patient presents clinical laboratory evaluations (including clinical biochemistry, hematology, and complete urinalysis) within, reference range for laboratory tests considered by the investigator as not clinically significant for inclusion within the study.
- •The patient is willing to suspend their current antihypertensive medications at the Day-21 screening visit. If the patient was in treatment with amlodipine before the Selection, the patient should discontinue this treatment in the Day -28 Selection.
排除标准
- •The patient has a diastolic blood pressure (DBP) nadir measured in the clinic in a sitting position> 119mmHg at Day -1 (the day before the randomization).
- •The patient has a baseline 24-hour MAP reading of insufficient quality (as defined in the protocol).
- •The patient is receiving or expects to receive a medication that is excluded, as indicated in the Excluded Medications section.
- •The patient has hypersensitivity to AII receptor blockers or calcium channel blockers.
- •The patient has a recent history (within 6 months) myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, stroke, or ischemic stroke transient (AIT)
- •The patient has clinically significant cardiac conduction abnormalities (eg, 3rd-degree atrioventricular block [AV], left bundle branch block [LBB], sick sinus syndrome, atrial fibrillation).
- •The patient presents hemodynamically significant left ventricular outflow obstruction due to aortic valve disease.
- •The patient has secondary arterial hypertension of any etiology (for example, renovascular disease, pheochromocytoma, Cushing´s syndrome).
- •The patient does not comply with the treatment with the study medications (less than 70% or greater than 130%) during the period of preparation with placebo.
- •The patient has renal dysfunction or severe kidney disease (based on a calculated creatinine clearance <30 mL / min / 1.73 m2) in the Selection.
- •The patient presents bilateral or unilateral confirmed or suspected stenosis of the renal artery.
- •The patient has a history of drug abuse (defined as the use of illicit drugs) or a history of alcohol abuse (defined as the regular or periodic consumption of more than 2 alcoholic beverages per day) within the last 2 years.
- •The patient has a history of cancer without remission in at least the last 5 years before the first dose of the study drug. (This criterion does not apply to patients with basal cell carcinoma or squamous cell carcinoma in Stage 1).
- •The patient suffers from diabetes mellitus type 1 or poorly controlled type 2 diabetes mellitus (HbA1c> 8.0%).
- •The patient has hyperkalemia defined by the range of normal reference values of the central laboratory.
- •The patient has a concentration of alanine aminotransferase (ALT) greater than 2.5 times the normal upper limit value, active liver disease, or jaundice.
- •The patient has a circumference of the upper arm less than 24 cm or greater than 42 cm.
- •The patient works on a rotating night schedule (defined as from 11 PM [23:00 hours] until 7:00 AM [7:00 hours]) every two nights.
- •The patient is not willing or unable to comply with the protocol or scheduled appointments.
- •The patient is unable to understand oral or written English, or any other language in which a certified translation of the approved informed consent is available.
- •If the patient is a woman, if she is pregnant, if she intends to become pregnant during the course of the study, or if she is breastfeeding.
- •The patient is currently participating in another experimental study or has participated in an experimental study within 30 days prior to randomization.
- •The patient is an employee of the study center, or is an immediate family member (eg spouse, parent, child, sibling) of an employee of the study center who is involved in
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