Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000292572
Ethics application status
Not yet submitted
Date submitted
8/07/2006
Date registered
11/07/2006
Date last updated
11/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
DORADO – Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension
Scientific title
DORADO – A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Evaluate the Efficacy and Safety of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Four or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311)
Secondary ID [1] 275 0
Myogen Inc: Protocol DAR-311
Universal Trial Number (UTN)
Trial acronym
DORADO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 1266 0
Condition category
Condition code
Cardiovascular 1352 1352 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double-blind, placebo-controlled research 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 determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of four or more antihypertensive drugs, including a diuretic. Subjects will be randomized to one of three doses of darusentan (50, 100, or 300 mg qd) administered orally. The treatment period for this trial is 14 weeks.
Intervention code [1] 1192 0
Treatment: Drugs
Comparator / control treatment
Placebo administered orally
Control group
Placebo

Outcomes
Primary outcome [1] 1843 0
Change from baseline in trough sitting systolic blood pressure measured by sphygmomanometry
Timepoint [1] 1843 0
The 14 week Treatment Period
Secondary outcome [1] 3237 0
Change from baseline in trough sitting diastolic blood pressure measured by sphygmomanometry.
Timepoint [1] 3237 0
Time points: the 14 week Treatment Period
Secondary outcome [2] 3238 0
Change from baseline in mean 24-hour systolic and diastolic blood pressure as measured by ambulatory blood pressure monitoring.
Timepoint [2] 3238 0
Time points: the 14 week Treatment Period
Secondary outcome [3] 3239 0
Change from baseline in the percent of subjects who reach systolic blood pressure goal.
Timepoint [3] 3239 0
Time points: the 14 week Treatment Period
Secondary outcome [4] 3240 0
Change from baseline in estimated glomerular filtration rate (eGFR).
Timepoint [4] 3240 0
Time points: the 14 week Treatment Period

Eligibility
Key inclusion criteria
Subjects who are competent to provide written consent. Subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure greater than or equal to 130 mmHg- All other subjects must have a mean systolic blood pressure greater than or equal to 140 mmHg- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from four different classes of antihypertensive agents, including a diuretic- Female subjects of non-childbearing potential (post-menopausal for at least 2 years; surgically sterile).
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Average sitting systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg- Serum ALT or AST greater than or equal to 2X ULN- Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident (CVA) within 6 month; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia- Implanted pacemakers or implanted cardioverter defibrillator (ICD) - Symptomatic CHF requiring treatment- Hemodynamically significant valvular heart disease- Type I diabetes mellitus- Hemodialysis or peritoneal dialysis; or history of renal transplant- Diagnosis or recurrence of malignancy within the past 3 years- Sleep apnea, unless a recent sleep study demonstrates arterial oxygen saturation >90%, treated or untreated- Subjects who perform alternating shift or night work- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.

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 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
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment outside Australia
Country [1] 376 0
United States of America
State/province [1] 376 0

Funding & Sponsors
Funding source category [1] 1482 0
Name [1] 1482 0
Country [1] 1482 0
Primary sponsor type
Commercial sector/Industry
Name
Myogen, inc.
Address
Country
United States of America
Secondary sponsor category [1] 1306 0
None
Name [1] 1306 0
Nil
Address [1] 1306 0
Country [1] 1306 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
This is a placebo-controlled research 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 determine if darusentan is effective in reducing systolic blood pressure in subjects with resistant systolic hypertension, despite treatment with full doses of four or more antihypertensive drugs, including a diuretic. Subjects will be randomized to one of three doses of darusentan (50, 100, or 300 mg qd) versus placebo administered orally. The treatment period for this trial is 14 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35930 0
Address 35930 0
Country 35930 0
Phone 35930 0
Fax 35930 0
Email 35930 0
Contact person for public queries
Name 10381 0
Jane Poretz
Address 10381 0
7575 West 103rd Ave, #102
Westminster, CO 80021-5426
Country 10381 0
United States of America
Phone 10381 0
0011-1-303-410-6666
Fax 10381 0
Email 10381 0
Jane.Poretz@myogen.com
Contact person for scientific queries
Name 1309 0
Jane Poretz
Address 1309 0
7575 West 103rd Ave, #102
Westminster CO 80021-5426
Country 1309 0
United States of America
Phone 1309 0
0011-1-303-410-6666
Fax 1309 0
Email 1309 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.