Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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)
Secondary ID [1] 0 0
Protocol DAR-312-E
Universal Trial Number (UTN)
Trial acronym
Darusentan
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in mean 24-hour systolic and diastolic ambulatory blood pressure
Timepoint [1] 0 0
Baseline to Week 14
Primary outcome [2] 0 0
Percentage of subjects who reach systolic blood pressure goal
Timepoint [2] 0 0
Week 14
Primary outcome [3] 0 0
Change from baseline in estimated glomerular filtration rate (eGFR)
Timepoint [3] 0 0
Baseline to Week 14
Secondary outcome [1] 0 0
Change from baseline in trough sitting systolic and diastolic blood pressures
Timepoint [1] 0 0
Baseline to Week 14

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.
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
661
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Bedford
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maine
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Michigan
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Minnesota
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Montana
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Nevada
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New Jersey
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New York
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North Carolina
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Oklahoma
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Oregon
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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West Virginia
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United States of America
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Wisconsin
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Argentina
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Bahia Blanca
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Argentina
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Buenos Aires
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Corrientes
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Quilmes
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Argentina
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Rosario
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Argentina
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Santa Fe
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Brazil
State/province [39] 0 0
Rio de Janeiro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00389675
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00389675