None listed
Conditions
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.
Interventions
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
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.
Sponsors
Myogen, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed