Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000446561
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 – Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
Scientific title
A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo (Protocol DAR-312)
Secondary ID [1] 311 0
Myogen Inc: Protocol DAR-312
Universal Trial Number (UTN)
Trial acronym
DORADO-AC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 1419 0
Condition category
Condition code
Cardiovascular 1515 1515 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose: 50, 100, or 300 mg qd), an active comparator (guanfacine 1 mg qd), administered orally. The study drug will be titrated to an optimized dose at which predefined blood pressure criteria are achieved. The treatment period for this trial is 14 weeks.
Intervention code [1] 1404 0
Treatment: Drugs
Comparator / control treatment
Placebo, administered orally
Control group
Placebo

Outcomes
Primary outcome [1] 2093 0
The trough sitting systolic and diastolic blood pressures as measured by sphygmomanometry
Timepoint [1] 2093 0
Analyzed after 14 weeks of treatment with study drug.
Secondary outcome [1] 3607 0
1) Mean 24-hour systolic and diastolic blood pressure as measured by ambulatroy blood pressure monitoring (ABPM).
Timepoint [1] 3607 0
Change from baseline
Secondary outcome [2] 3608 0
2) Percent of subjects who reach systolic blood pressure goal.
Timepoint [2] 3608 0
Secondary outcome [3] 3609 0
3) Estimated glomerular filtration rate (eGFR), as analyzed after 14 weeks of treatment with study drug.
Timepoint [3] 3609 0
Change from baseline

Eligibility
Key inclusion criteria
1) Subjects who are competent to provide written consent; 2) Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 3) All other subjects must have an average sitting systolic blood pressure greater than or equal to 140 mmHg; 4) Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic; 5) 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) Average sitting systolic and diastolic blood pressure greater than or equal to 180 mmHg and 110 mmHg, respectively; 2) Subjects treated with a central alpha-2 agonist and/or imidazoline receptor agonist; 3) Left ventricular dysfunction; 4) Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) greater than 2 times the Upper Limit of Normal; 5) Subjects who have experienced myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months; or sick sinus syndrome or second or third degree atrioventricular block, atrial fibrillation or recurrent atrial tachycardia, recurrent ventricular tachycardia, or symptomatic bradycardia; 6) Implanted pacemakers or cardioverter defibrillator; 7) Symptomatic CHF requiring treatment; 8) Hemodynamically significant valvular heart disease; 9) Hemodialysis or peritoneal dialysis, or history of renal transplant; 10) Type I diabetes mellitus; 11) Diagnosis or recurrence of malignancy within the past 3 years; 12) Sleep apnea, unless a recent sleep study demonstrated arterial oxygenation saturation greater than 90%, treated or untreated; 13) Subjects who perform alternating shift or night work; 14) 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 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 during the conduct of the study
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 408 0
United States of America
State/province [1] 408 0

Funding & Sponsors
Funding source category [1] 1650 0
Commercial sector/Industry
Name [1] 1650 0
Myogen, Inc.
Country [1] 1650 0
Primary sponsor type
Commercial sector/Industry
Name
Myogen, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1459 0
None
Name [1] 1459 0
Nil
Address [1] 1459 0
Country [1] 1459 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
This is a randomized, double-blind, placebo- and active-controlled study of a new experimental drug called darusentan. The purpose of this study is to determine if darusentan is effective in reducing systolic and diastolic hypertension despite treatment with full doses of three or more antihypertensive drugs, including a diuretic. Subjects will be randomized to darusentan (optimized dose: 50, 100, or 300 mg qd), an active comparator (guanfacine 1 mg qd), or placebo, administered orally. The study drug will be titrated to an optimized dose at which predefined blood pressure criteria are achieved. The treatment period for this trial is 14 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27338 0
Address 27338 0
Country 27338 0
Phone 27338 0
Fax 27338 0
Email 27338 0
Contact person for public queries
Name 10593 0
Jane Poretz, Director, Clinical Operations
Address 10593 0
Myogen Inc.
7575 West 103rd Ave
#102
Westminster CO 80021-5426
Country 10593 0
United States of America
Phone 10593 0
0011 303 410 6666
Fax 10593 0
Email 10593 0
Jane.Poretz@Myogen.com
Contact person for scientific queries
Name 1521 0
Jane Poretz, Director, Clinical Operations
Address 1521 0
Myogen Inc.
7575 West 103rd Ave
#102
Westminster CO 80021-5426
Country 1521 0
United States of America
Phone 1521 0
0011 303 410 6666
Fax 1521 0
Email 1521 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.