Resistant hypertension MedDRA version: 8.1 Level: LLT Classification code 10038274 Term: Refractory hypertension
Conditions
Interventions
Product Name: Darusentan
Product Code: LU135252 and GS-9377
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Darusentan
CAS Number: 171714-84-4
Current Sponsor code: LU 135252
Other descri
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must be competent to provide written informed consent - Aged 35 to 80 years - Subjects must have resistant systolic hypertension consistent with current clinical guidelines for the treatment of hypertension. Subjects with diabetes and/or CKD must have an average sitting SBP of =130 mmHg and all other subjects must have an average sitting SBP =140 mmHg at Screening. - Subjects must be receiving, and adhering to, full doses of appropriate guideline-recommended antihypertensive drugs from three classes of antihypertensive agents, including a diuretic. - Subjects must have a BMI of 20 to 43 kg/m2, inclusive. If >43kg/m2, the subject must have an upper arm circumference =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Average sitting systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg - Serum ALT or AST =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) - Subjects with a historical or current diagnosis of symptomatic or asymptomatic CHF, treated or untreated. - Hemodynamically significant valvular heart disease - Type I diabetes mellitus - Hemodialysis or peritoneal dialysis; or history of solid organ transplant (e.g., kidney, heart). - Diagnosis or recurrence of malignancy within the past 3 years - Subjects with sleep apnea are excluded, unless a post-treatment sleep study has confirmed treatment efficacy and there are no recordings of blood oxygen saturation (SpO2) <90% at any time during the testing period. - 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 - Use of thiazolidinedione (i.e., glitazone) class of anti-diabetic medications (e.g., rosiglitazone, pioglitazone; alone or in combination pills) at or within 4 weeks of Screening (Visit 1). Subjects should not initiate treatment with thiazolidinediones at any time during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if darusentan is effective in reducing SBP in subjects with RHTN, despite treatment 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 trough sitting DBP, mean 24-hour ambulatory blood pressure, percent of subjects meeting SBP goal, and eGFR, and to evaluate the safety and tolerability of the study drug in the subject population.;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. | — |
Countries
Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed