DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: Hypertension

Treatments: Drug: Guanfacine; Drug: Darusentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389675

Protocol DAR-312-E

Details and patient eligibility

About

This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. Darusentan in not currently approved by the United States Food and Drug Administration (FDA), which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.

Enrollment: 661 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

SELECTED INCLUSION CRITERIA:

1. Subjects must be competent to provide written informed consent;
2. Subjects must have completed the Maintenance Period of the DAR-312 study.

SELECTED EXCLUSION CRITERIA:

1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 due to a study drug-related AE;
2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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661 participants in 2 patient groups

Darusentan

Experimental group

Description:

Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily

Treatment:

Drug: Darusentan

Guanfacine

Active Comparator group

Description:

Guanfacine 1 mg capsules administered orally once daily

Treatment:

Drug: Guanfacine