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)
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| ClinicalTrials.gov Identifier: NCT00389675 |
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Recruitment Status :
Terminated
(Study DAR-312 did not meet its primary co-endpoints.)
First Posted : October 19, 2006
Last Update Posted : January 6, 2014
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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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
MedlinePlus Genetics related topics:
Hypertension
| Arm | Intervention/treatment |
|---|---|
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Experimental: Darusentan
Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
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Drug: Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Other Name: LU 135252 |
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Active Comparator: Guanfacine
Guanfacine 1 mg capsules administered orally once daily
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Drug: Guanfacine
Guanfacine 1 mg capsules administered orally once daily |
Primary Outcome Measures :
- Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure [ Time Frame: Baseline to Week 14 ]
- Percentage of subjects who reach systolic blood pressure goal [ Time Frame: Week 14 ]
- Change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Week 14 ]
Secondary Outcome Measures :
- Change from baseline in trough sitting systolic and diastolic blood pressures [ Time Frame: Baseline to Week 14 ]
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| Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
SELECTED INCLUSION CRITERIA:
- Subjects must be competent to provide written informed consent;
- Subjects must have completed the Maintenance Period of the DAR-312 study.
SELECTED EXCLUSION CRITERIA:
- 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;
- 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
Locations
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Sponsors and Collaborators
Gilead Sciences
Additional Information:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00389675 |
| Other Study ID Numbers: |
Protocol DAR-312-E |
| First Posted: | October 19, 2006 Key Record Dates |
| Last Update Posted: | January 6, 2014 |
| Last Verified: | January 2014 |
Additional relevant MeSH terms:
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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 |