Overview

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

Status:
Terminated

Trial end date:
2010-04-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Gilead Sciences

Treatments:

Darusentan
LU 135252

Criteria

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