Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000447550
Ethics application status
Not yet submitted
Date submitted
17/10/2006
Date registered
18/10/2006
Date last updated
18/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
DORADO-AC-EX – A Double-Blind, Active-Controlled, Long-Term Safety Extension Study to the Phase 3 DORADO-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] 312 0
Myogen Inc: Protocol DAR-312-E
Universal Trial Number (UTN)
Trial acronym
DORADO-AC-EX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 1420 0
Condition category
Condition code
Cardiovascular 1516 1516 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. The purpose of this study is to evaluate the long-term safety of darusentan (50, 100, or 300 mg qd) as compared to an active control (guanfacine 1 mg qd), administered orally. Subjects will be exposed to study drug for an estimated average of 1 year.
Intervention code [1] 1405 0
Treatment: Drugs
Comparator / control treatment
Active control (guanfacine 1 mg qd), administered orally
Control group
Active

Outcomes
Primary outcome [1] 2094 0
Long-term safety of darusentan in subjects with resistant systolic hypertension (despite treatment with full doses of three or more antihypertensive medications, including a diuretic)
Timepoint [1] 2094 0
Measured after 14 weeks of study drug exposure and various other timepoints throughout the approximately 1 year study duration.
Secondary outcome [1] 3610 0
1) Trough sitting systolic and diastolic blood pressures obtained using sphygmomanometry.
Timepoint [1] 3610 0
Change from baseline
Secondary outcome [2] 3611 0
2) Mean 24-hour systolic and diastolic blood pressures as measured by ambulatory blood pressure monitoring (ABPM).
Timepoint [2] 3611 0
Change from baseline
Secondary outcome [3] 3612 0
3) Percent of subjects who reach systolic blood pressure goal.
Timepoint [3] 3612 0
Secondary outcome [4] 3613 0
4) Estimated glomerular filtration rate (eGFR), as measured after 14 weeks of study drug exposure and various other timepoints throughout the approximately 1 year study duration.
Timepoint [4] 3613 0
Change from baseline

Eligibility
Key inclusion criteria
1) Subjects must be competent to provide written informed consent; 2) Subjects must have completed participation in the DAR-312; 3) Female subjects must be of non-childbearing potential (post menopausal for at least 2 years or surgically sterile).
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 adverse event (AE); 2) Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 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)
Centralized randomization by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization; Stratification by race & 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
Subjects, investigators (and staff), and the sponsor (Myogen, Inc.) will be blinded to subject assignment for the duration of the clinical study
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment outside Australia
Country [1] 409 0
United States of America
State/province [1] 409 0

Funding & Sponsors
Funding source category [1] 1651 0
Commercial sector/Industry
Name [1] 1651 0
Myogen, Inc.
Country [1] 1651 0
Primary sponsor type
Commercial sector/Industry
Name
Myogen, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1460 0
None
Name [1] 1460 0
Nil
Address [1] 1460 0
Country [1] 1460 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27339 0
Address 27339 0
Country 27339 0
Phone 27339 0
Fax 27339 0
Email 27339 0
Contact person for public queries
Name 10594 0
Jane Poretz, Director, Clinical Operations
Address 10594 0
Myogen Inc.
7575 West 103rd Ave
#102
Westminster CO 80021-5426
Country 10594 0
United States of America
Phone 10594 0
0011 303 410 6666
Fax 10594 0
Email 10594 0
[email protected]
Contact person for scientific queries
Name 1522 0
Jane Poretz, Director, Clinical Operations
Address 1522 0
Myogen Inc.
7575 West 103rd Ave
#102
Westminster CO 80021-5426
Country 1522 0
United States of America
Phone 1522 0
0011 303 410 6666
Fax 1522 0
Email 1522 0
[email protected]

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.