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 PlaceboDORADO-AC: Dosis Óptimas de Darusentan Comparadas con un Control Activo en Hipertensión ResistenteEstudio fase 3, aleatorizado, multicéntrico, doble ciego, controlado con placebo/medicación activa, de grupos paralelos para evaluar la eficacia y seguridad de Darusentan en pacientes con hipertensión resistente que reciben tratamiento combinado con tres o más medicamentos antihipertensivos, incluyendo un diurético, comparado con Guanfacina o placebo - DORADO-AC

Phase 1

• Conditions: Resistant hypertension; MedDRA version: 8.1Level: LLTClassification code 10038274Term: Refractory hypertension

• Registration Number: EUCTR2006-003547-23-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-26
• Study Completion: 2009-08-19
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 770

Inclusion Criteria

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, or 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 for at least 2 years or surgically sterile.
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

Exclusion Criteria

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 symptomatic CHF requiring treatment.
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 renal transplant.
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 recent (within 30 days of Screening [Visit 1]) sleep study demonstrates no recordings of arterial oxygen saturation (SaO2) <90%, treated or untreated, 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified