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

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00353574

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: darusentan	Phase III

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Darusentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary safety measures are based on general safety assessments including additional emphasis on predefined clinical assessments. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
The primary efficacy measures are change in trough sitting systolic and diastolic blood pressures. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy measurements include: change in mean 24-hour systolic and diastolic ambulatory blood pressures. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Percent of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 50 mg	Drug: darusentan 3 tablets QD, PO
2: Experimental 100 mg	Drug: darusentan 3 tablets QD, PO
3: Experimental 300 mg	Drug: darusentan 3 tablets QD, PO

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353574

Show 75 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gilead Sciences, Inc. ( Kathleen DeHaven, Associate Director, Clinical Trial Management )
Study ID Numbers:	DAR-311-E
Study First Received:	July 17, 2006
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00353574 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Resistant Hypertension

Study placed in the following topic categories:

Diuretics
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009