DORADO-EX – A Dose-Blinded, Long-Term, Safety Extension Study to the Phase 3 DORADO Study of Darusentan in Resistant Hypertensio

• Conditions: Resistant Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12606000310561
• Lead Sponsor: Myogen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) Subjects who have completed the Treatment Period of clinical trial DAR-311; 2) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from four different classes of antihypertensive agents, including a diuretic.

Exclusion Criteria

1) Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related AE; 2) Subjects who experience a study drug-related SAE during the DAR-311 study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety outcome: will be based on general safety assessments but will have additional emphasis placed on predefined clinical assessments measures.<br>[Study duration];Primary efficacy outcome: change from baseline in trough sitting systolic blood pressure measured by sphygmomanometry[Change from baseline after 14 weeks of treatment]

Secondary Outcome Measures

Name	Time	Method
1) trough sitting diastolic blood pressure measured by sphygmomanometry[Change from baseline];2) mean 24-hour systolic and diastolic blood pressure as measured by ambulatory blood pressure monitoring[Change from baseline];3) the percent of subjects who reach systolic blood pressure goal[Change from baseline];4) estimated glomerular filtration rate (eGFR).[Change from baseline]