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 (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00389675
First received: October 17, 2006
Last updated: January 3, 2014
Last verified: January 2014
  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
Drug: 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:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]
  • Percentage of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in trough sitting systolic and diastolic blood pressures [ Time Frame: Baseline to 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: Darusentan
Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Drug: Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Other Name: LU 135252
Active Comparator: Guanfacine
Guanfacine 1 mg capsules administered orally once daily
Drug: Guanfacine
Guanfacine 1 mg capsules administered orally once daily

  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:
No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00389675     History of Changes
Other Study ID Numbers: Protocol DAR-312-E
Study First Received: October 17, 2006
Last Updated: January 3, 2014
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 April 17, 2014