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

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Hypertension

Treatments: Drug: Darusentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00353574

DAR-311-E

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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282 participants in 3 patient groups

Darusentan 50 mg

Experimental group

Description:

Darusentan 50 mg administered orally once daily

Treatment:

Drug: Darusentan

Darusentan 100 mg

Experimental group

Description:

Darusentan 100 mg administered orally once daily

Treatment:

Drug: Darusentan

Darusentan 300 mg

Experimental group

Description:

Darusentan 300 mg administered orally once daily

Treatment:

Drug: Darusentan