EUCTR2006-001898-25-DE进行中（未招募）不适用
DORADO - Fixed Doses of Darusentan as Compared to Placebo in ResistantHypertensionA Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311) - DORADO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 352
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects must be competent to provide written informed consent
- •- Aged 35 to 80 years
- •- Subjects must have resistant systolic hypertension consistent with current clinical guidelines for the treatment of hypertension. Subjects with diabetes and/or CKD must have an average sitting SBP of =130 mmHg and all other subjects must have an average sitting SBP =140 mmHg at Screening.
- •- Subjects must be receiving, and adhering to, full doses of appropriate guideline-recommended antihypertensive drugs from three classes of antihypertensive agents, including a diuretic.
- •- Subjects must have a BMI of 20 to 43 kg/m2, inclusive. If >43kg/m2, the subject must have an upper arm circumference <42 cm at Screening (Visit 1).
- •- Subjects must have an Egfr of = 30 MI/min/1.73m2 at Screening.
- •- Female subjects must be of non-childbearing potential, i.e. documented post-menopausal (cessation of regular menstrual periods) for at least 2 years or surgically sterile (i.e., hysterectomy and/or bilateral oophorectomy). Post-menopausal female subjects who are not surgically sterile will be required to use a double-barrier method of birth control throughout study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Average sitting systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg
- •- Serum ALT or AST =2X ULN
- •- Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
- •- Implanted pacemakers or implanted cardioverter defibrillator (ICD)
- •- Subjects with a historical or current diagnosis of symptomatic or asymptomatic CHF, treated or untreated.
- •- Hemodynamically significant valvular heart disease
- •- Type I diabetes mellitus
- •- Hemodialysis or peritoneal dialysis; or history of solid organ transplant (e.g., kidney, heart).
- •- Diagnosis or recurrence of malignancy within the past 3 years
- •- Subjects with sleep apnea are excluded, unless a post-treatment sleep study has confirmed treatment efficacy and there are no recordings of blood oxygen saturation (SpO2) <90% at any time during the testing period.
- •- Subjects who perform alternating shift or night work
- •- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
- •- Use of thiazolidinedione (i.e., glitazone) class of anti-diabetic medications (e.g., rosiglitazone, pioglitazone; alone or in combination pills) at or within 4 weeks of Screening (Visit 1). Subjects should not initiate treatment with thiazolidinediones at any time during the study.
研究者
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