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 inSubjects with Resistant Systolic Hypertension Receiving Combination Therapy withFour or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)DORADO - Dosis fijas de darusentán en comparación con placebo en la hipertensión arterial resistenteEstudio en fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y la seguridad de dosis fijas de darusentán en sujetos con hipertensión sistólica resistente tratados con una combinación de cuatro o más antihipertensivos, incluido un diurético. - DORADO
- Conditions
- Resistant hypertensionLa hipertensión arterial resistenteMedDRA version: 9.1Level: LLTClassification code 10038274Term: Refractory hypertension
- Registration Number
- EUCTR2006-001898-25-ES
- Lead Sponsor
- Myogen, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 352
- 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 four classes of antihypertensive agents, including a diuretic.
- Subjects must have a BMI of 20 to 40 kg/m2, inclusive, at Screening.
- Subjects must have an Egfr of = 30 MI/min/1.73m2 at Screening.
- Female subjects must be of non-childbearing potential
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
- 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)
- Symptomatic CHF requiring treatment
- Hemodynamically significant valvular heart disease
- Type I diabetes mellitus
- Hemodialysis or peritoneal dialysis; or history of renal transplant
- Diagnosis or recurrence of malignancy within the past 3 years
- Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation >90%
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to determine if darusentan is effective in reducing SBP in subjects with RHTN, despite treatment with full doses of four or more antihypertensive drugs, including a diuretic. ;Secondary Objective: Secondary objectives of this study are to examine the effect of darusentan on trough sitting DBP, mean 24-hour ambulatory blood pressure, percent of subjects meeting SBP goal, and eGFR, and to evaluate the safety and tolerability of the study drug in the subject population. ;Primary end point(s): The primary endpoint is change from baseline to Week 14 in trough sitting SBP<br>measured by sphygmomanometry.
- Secondary Outcome Measures
Name Time Method