DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-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

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389675

Acronym

Darusentan

Enrollment

661

Registered

2006-10-19

Start date

2007-05-31

Completion date

2010-05-31

Last updated

2014-01-06

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

Conditions

Hypertension

Brief 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.

Interventions

DRUGGuanfacine

Guanfacine 1 mg capsules administered orally once daily

DRUGDarusentan

Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure	Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal	Week 14
Change from baseline in estimated glomerular filtration rate (eGFR)	Baseline to Week 14

Secondary

Measure	Time frame
Change from baseline in trough sitting systolic and diastolic blood pressures	Baseline to Week 14

Countries

Argentina, Australia, Brazil, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026