Overview

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

Status:
Terminated

Trial end date:
2010-05-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Gilead Sciences

Treatments:

Darusentan
Guanfacine
LU 135252

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.