DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

Study Overview
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Brief Summary
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This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

Official Title
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DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Darusentan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have completed the Treatment Period of clinical trial DAR-311 Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic Exclusion Criteria: Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE) Treatment with another endothelin receptor antagonist within 6 months of study entry

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darusentan 50 mg<br>Darusentan 50 mg administered orally once daily | Drug: Darusentan<br>* Darusentan capsules administered orally once daily<br>|
| Experimental: Darusentan 100 mg<br>Darusentan 100 mg administered orally once daily | Drug: Darusentan<br>* Darusentan capsules administered orally once daily<br>|
| Experimental: Darusentan 300 mg<br>Darusentan 300 mg administered orally once daily | Drug: Darusentan<br>* Darusentan capsules administered orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in trough sitting systolic and diastolic blood pressure |  | Baseline to Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean 24-hour systolic and diastolic ambulatory blood pressures. |  | Baseline to Week 14 | 
| Percentage of subjects who reach systolic blood pressure goal |  | Week 14 | 
| Change in estimated glomerular filtration rate (eGFR) |  | Baseline to Week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant Hypertension