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

TERMINATEDPHASE3

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)

NCT00389675•Gilead Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (99)

Alabama Internal Medicine, PC

Birmingham, Alabama, United States

Greystone Medical Research, LLC

Birmingham, Alabama, United States

The Heart Center, PC

Huntsville, Alabama, United States

Mulberry Medical Associates, PC

Montgomery, Alabama, United States

Arizona Center for Clinical Research

Glendale, Arizona, United States

Cardiovascular Consultants, Ltd.

Glendale, Arizona, United States

Lovelace Scientific Resource, Inc.

Phoenix, Arizona, United States

Cochise Clinical Research

Sierra Vista, Arizona, United States

Southwest Heart

Tucson, Arizona, United States

HealthFirst Physicians of AR, PA dba Convenient Care Clinic

Hot Springs, Arkansas, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

February 1, 2010

Completion Date

May 1, 2010

Last Updated

January 6, 2014

Enrollment

661

ACTUAL participants

Conditions

Hypertension

Interventions

Darusentan

DRUG

Guanfacine

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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