None listed
Conditions
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.
Interventions
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 d
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.
Sponsors
Myogen, inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed