ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00389675
Recruitment Status : Terminated (Study DAR-312 did not meet its primary co-endpoints.)
First Posted : October 19, 2006
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Darusentan Drug: Guanfacine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 661 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : May 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ]
  2. Percentage of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ]
  3. Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ]

Secondary Outcome Measures :
  1. Change from baseline in trough sitting systolic and diastolic blood pressures [ Time Frame: Baseline to Week 14 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389675


  Show 99 Study Locations
Sponsors and Collaborators
Gilead Sciences

Additional Information:
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00389675     History of Changes
Other Study ID Numbers: Protocol DAR-312-E
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Guanfacine
Darusentan
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Endothelin Receptor Antagonists