DORADO-AC-EX – A Double-Blind, Active-Controlled, Long-Term Safety Extension Study to the Phase 3 DORADO-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension

A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000447550

Acronym

DORADO-AC-EX

Enrollment

700

Registered

2006-10-18

Start date

2007-04-09

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. The purpose of this study is to evaluate the long-term safety of darusentan (50, 100, or 300 mg qd) as compared to an active control (guanfacine 1 mg qd), administered orally. Subjects will be exposed to study drug for an estimated average of 1 year.

Interventions

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

1) Subjects must be competent to provide written informed consent; 2) Subjects must have completed participation in the DAR-312; 3) Female subjects must be of non-childbearing potential (post menopausal for at least 2 years or surgically sterile).

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 adverse event (AE); 2) Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study.

Outcome results