EUCTR2006-003547-23-BE进行中（未招募）不适用
DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant HypertensionA Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or MoreAntihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo - DORADO-AC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 770
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
- •1. Subjects must be competent to provide written informed consent.
- •2. Subjects must be 35-80 years of age.
- •3. Subjects must have resistant systolic hypertension consistent with current clinical guidelines for the treatment of hypertension.
- •4. Subjects with diabetes and/or CKD must have an average sitting SBP =130 mmHg.
- •5. All other subjects must have an average sitting SBP =140 mmHg.
- •6. Subjects must be receiving, and adhering to, full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic.
- •7. Subjects must have a BMI of 20 to 43 kg/m2, inclusive. If BMI >43 kg/m2, the subject must have an upper arm circumference <42 cm at Screening (Visit 1).
- •8. Subjects must have an eGFR of = 30mL/min/1.73m2 at Screening (Visit 1).
- •9. 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).
- •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
- •1. Subjects with an average sitting SBP of =180 mmHg or DBP of =110 mmHg.
- •2. Subjects with left ventricular (LV) systolic dysfunction.
- •3. Subjects with a serum ALT or AST >2xULN.
- •4. Subjects who have experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the Screening Visit (Visit 1).
- •5. Subjects with sick sinus syndrome or second or third degree atrioventricular (AV) block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), a history of recurrent ventricular tachycardia, or symptomatic bradycardia.
- •6. Subjects with implanted pacemakers or an implanted cardioverter defibrillator.
- •7. Subjects with a historical or current diagnosis of symptomatic or asymptomatic CHF, treated or untreated.
- •8. Subjects with hemodynamically significant valvular heart disease.
- •9. Subjects with Type 1 diabetes mellitus.
- •10. Subjects on hemodialysis or peritoneal dialysis at the time of Screening (Visit 1) and subjects with a history of solid organ transplant (e.g., kidney, heart).
- •11. Subjects who have had a diagnosis or recurrence of malignancy within the past 3 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- •12. 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.
- •13. Subjects who perform alternating shift or night work.
- •14. Subjects treated with a central alpha-2 agonist and/or an imidazoline receptor agonist (i.e., guanfacine, clonidine, moxonidine) within 90 days of Screening.
- •15. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks of the Screening Visit (Visit 1).
- •16. Subjects not on stable doses of all concomitant medications for a minimum of 4 weeks prior to Screening (Visit 1), and subjects treated with any protocol-specified prohibited medications (e.g. thiazolidinedione).
研究者
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