Resistant hypertension MedDRA version: 8.1 Level: LLT Classification code 10038274 Term: Refractory hypertension
Conditions
Interventions
Product Name: Darusentan
Product Code: LU 135252
Pharmaceutical Form: Capsule*
INN or Proposed INN: Darusentan
CAS Number: 171714-84-4
Current Sponsor code: LU 135252
Concentration unit: mg milligram(
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be competent to provide written informed consent. 2. Subjects must be 35-80 years of age. 3. Subjects must have resistant systolic hypertension consistent with current clinical guidelines for the treatment of hypertension. 4. Subjects with diabetes and/or CKD must have an average sitting SBP =130 mmHg. 5. All other subjects must have an average sitting SBP =140 mmHg. 6. Subjects must be receiving, and adhering to, full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic. 7. Subjects must have a BMI of 20 to 43 kg/m2, inclusive, or an upper arm circumference =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with an average sitting SBP of =180 mmHg or DBP of =110 mmHg. 2. Subjects with left ventricular (LV) systolic dysfunction. 3. Subjects with a serum ALT or AST >2xULN. 4. Subjects who have experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the Screening Visit (Visit 1). 5. Subjects with sick sinus syndrome or second or third degree atrioventricular (AV) block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), a history of recurrent ventricular tachycardia, or symptomatic bradycardia. 6. Subjects with implanted pacemakers or an implanted cardioverter defibrillator. 7. Subjects with symptomatic CHF requiring treatment. 8. Subjects with hemodynamically significant valvular heart disease. 9. Subjects with Type 1 diabetes mellitus. 10. Subjects on hemodialysis or peritoneal dialysis at the time of Screening (Visit 1) and subjects with a history of renal transplant. 11. Subjects who have had a diagnosis or recurrence of malignancy within the past 3 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix. 12. Subjects with sleep apnea are excluded, unless a recent (within 30 days of Screening [Visit 1]) sleep study demonstrates no recordings of arterial oxygen saturation (SaO2) <90%, treated or untreated, at any time during the testing period. 13. Subjects who perform alternating shift or night work. 14. Subjects treated with a central alpha-2 agonist and/or an imidazoline receptor agonist (i.e., guanfacine, clonidine, moxonidine) within 90 days of Screening. 15. Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks of the Screening Visit (Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The co-primary endpoints are the change from baseline to Week 14 in trough sitting SBP and trough sitting DBP, as measured by sphygmomanometry.;Main Objective: The primary objective of this study is to determine if darusentan is effective in reducing SBP and DBP in subjects who have RHTN, despite being treated with full doses of three or more antihypertensive drugs, including a diuretic.;Secondary Objective: Secondary objectives of this study are to examine the effect of darusentan on mean 24-hour ambulatory BP, percent of subjects meeting SBP goal, and eGFR. The safety and tolerability of the darusentan in the subject population will also be evaluated. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Spain, United Kingdom
Outcome results
None listed