Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000310561
Ethics application status
Not yet submitted
Date submitted
18/07/2006
Date registered
20/07/2006
Date last updated
20/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
DORADO-EX – A Dose-Blinded, Long-Term, Safety Extension Study to the Phase 3 DORADO Study of Darusentan in Resistant Hypertension
Scientific title
DORADO-EX – A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four of More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)
Secondary ID [1] 282 0
Myogen Inc: Protocol DAR-311-E
Universal Trial Number (UTN)
Trial acronym
DORADO-EX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 1281 0
Condition category
Condition code
Cardiovascular 1368 1368 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dose-blinded, long-term safety and efficacy study of a new experimental drug called darusentan. Darusentan is not currently approved by the Therapeutic Goods Administration (TGA) for use in Australia, which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of four or more antihypertensive medications, including a diuretic. Three doses of darusentan (50, 100, or 300 mg qd) that are orally administered will be examined for the long-term duration of the study.
Intervention code [1] 1210 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1870 0
Primary safety outcome: will be based on general safety assessments but will have additional emphasis placed on predefined clinical assessments measures.
Timepoint [1] 1870 0
Study duration
Primary outcome [2] 1871 0
Primary efficacy outcome: change from baseline in trough sitting systolic blood pressure measured by sphygmomanometry
Timepoint [2] 1871 0
Change from baseline after 14 weeks of treatment
Secondary outcome [1] 3291 0
1) trough sitting diastolic blood pressure measured by sphygmomanometry
Timepoint [1] 3291 0
Change from baseline
Secondary outcome [2] 3292 0
2) mean 24-hour systolic and diastolic blood pressure as measured by ambulatory blood pressure monitoring
Timepoint [2] 3292 0
Change from baseline
Secondary outcome [3] 3293 0
3) the percent of subjects who reach systolic blood pressure goal
Timepoint [3] 3293 0
Change from baseline
Secondary outcome [4] 3294 0
4) estimated glomerular filtration rate (eGFR).
Timepoint [4] 3294 0
Change from baseline

Eligibility
Key inclusion criteria
1) Subjects who have completed the Treatment Period of clinical trial DAR-311; 2) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from four different classes of antihypertensive agents, including a diuretic.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related AE; 2) Subjects who experience a study drug-related SAE during the DAR-311 study.

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation; Stratification by race and co-morbid factor (diabetes, chronic kidney disease or both)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 379 0
United States of America
State/province [1] 379 0

Funding & Sponsors
Funding source category [1] 1503 0
Commercial sector/Industry
Name [1] 1503 0
Myogen, Inc.
Country [1] 1503 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Myogen, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1320 0
None
Name [1] 1320 0
Nil
Address [1] 1320 0
Country [1] 1320 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
This is a dose-blinded, long-term safety and efficacy study of a new experimental drug called darusentan. Darusentan is not currently approved by the Therapeutic Goods Administration (TGA) for use in Australia, which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of four or more antihypertensive medications, including a diuretic. Three doses of darusentan (50, 100, or 300 mg qd) that are orally administered will be examined for the long-term duration of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35781 0
Address 35781 0
Country 35781 0
Phone 35781 0
Fax 35781 0
Email 35781 0
Contact person for public queries
Name 10399 0
Jane Poretz
Address 10399 0
7575 West 103rd Ave., #102
Westminster, CO 80021-5426
Country 10399 0
United States of America
Phone 10399 0
0011-4-303-410-6666
Fax 10399 0
Email 10399 0
Jane.Poretz@Myogen.com
Contact person for scientific queries
Name 1327 0
Jane Poretz
Address 1327 0
7575 West 103rd Ave., #102
Westminster CO 80021-5426
Country 1327 0
United States of America
Phone 1327 0
0011-1-303-410-6666
Fax 1327 0
Email 1327 0
Jane.Poretz@Myogen.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.