DORADO-AC – Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertensio

Phase 3

• Conditions: Resistant Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12606000446561
• Lead Sponsor: Myogen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1) Subjects who are competent to provide written consent; 2) Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 3) All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg; 4) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic; 5) Female subjects must be of non-childbearing potential (post-menopausal for at least 2 years or surgically sterile).

Exclusion Criteria

1) Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively; 2) Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist; 3) Left ventricular dysfunction; 4) Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 2 times the Upper Limit of Normal; 5) Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia; 6) Implanted pacemakers or cardioverter defibrillator; 7) Symptomatic CHF requiring treatment; 8) Hemodynamically significant valvular heart disease; 9) Hemodialysis or peritoneal dialysis, or history of renal transplant; 10) Type I diabetes mellitus; 11) Diagnosis or recurrence of malignancy within the past 3 years; 12) Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than 90%, treated or untreated; 13) Subjects who perform alternating shift or night work; 14) 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
• Study Design: Not specified