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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014