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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00389675
Registration number
NCT00389675
Ethics application status
Date submitted
17/10/2006
Date registered
19/10/2006
Date last updated
6/01/2014
Titles & IDs
Public title
DORADO-AC-EX - A Long-Term Safety Extension Study to the Phase 3 DORADOC-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
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Scientific 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)
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Secondary ID [1]
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Protocol DAR-312-E
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Universal Trial Number (UTN)
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Trial acronym
Darusentan
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Darusentan
Treatment: Drugs - Guanfacine
Experimental: Darusentan - Darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily
Active comparator: Guanfacine - Guanfacine 1 mg capsules administered orally once daily
Treatment: Drugs: Darusentan
Darusentan capsules at a dose of 50, 100, or 300 mg administered orally once daily
Treatment: Drugs: Guanfacine
Guanfacine 1 mg capsules administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 14
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Primary outcome [2]
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Percentage of subjects who reach systolic blood pressure goal
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Assessment method [2]
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Timepoint [2]
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Week 14
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Primary outcome [3]
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Change from baseline in estimated glomerular filtration rate (eGFR)
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Assessment method [3]
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Timepoint [3]
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Baseline to Week 14
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Secondary outcome [1]
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Change from baseline in trough sitting systolic and diastolic blood pressures
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 14
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Eligibility
Key inclusion 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.
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Minimum age
35
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2010
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Sample size
Target
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Accrual to date
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Final
661
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford
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Recruitment hospital [2]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Bedford
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Recruitment postcode(s) [2]
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- Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Illinois
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Argentina
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Bahia Blanca
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Buenos Aires
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Ciudad de Buenos Aires
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Quilmes
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Rosario
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Santa Fe
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Brazil
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Rio de Janeiro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00389675
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00389675
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