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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

This study has been terminated.
(Study DAR-312 did not meet its primary co-endpoints.)
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00389675
First received: October 17, 2006
Last updated: March 23, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: darusentan (LU 135252) and guanfacine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Primary efficacy measures include (i) change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressures, (ii) percent of subjects who reach systolic blood pressure goal, and (iii) change from baseline in eGFR [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy measures are change from baseline in trough sitting systolic and diastolic blood pressures, and the primary safety measures are based on general safety assessments including additional emphasis on predefined clinical assessments [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Enrollment: 661
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
50, 100, or 300 mg
 Drug: darusentan (LU 135252) and guanfacine
1 capsule QD, PO
Other Name: guanfacine
Active Comparator: 2
1 mg
 Drug: darusentan (LU 135252) and guanfacine
1 capsule QD, PO
Other Name: guanfacine

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389675

  Show 99 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: Luiz.Belardinelli, Senior Vice President, Clinical Research, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00389675     History of Changes
Other Study ID Numbers: Protocol DAR-312-E
Study First Received: October 17, 2006
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Guanfacine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013