Resistant hypertension MedDRA version: 8.1 Level: LLT Classification code 10038274 Term: Refractory hypertension
Conditions
Interventions
Product Name: Darusentan
Product Code: LU 135252 or GS-9377
Pharmaceutical Form: Capsule*
INN or Proposed INN: Darusentan
CAS Number: 17
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 have completed the Maintenance Period (i.e., through Week 14) of the DAR-312 study and may be on or off study drug, with the exception of subjects who discontinued study drug due to a study drug-related AE. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who discontinue treatment with study drug prior to the end of the Maintenance Period in DAR-312 do to a study drug-related AE. 2. Subjects who experience a study drug-related serious adverse event (SAE) during the DAR-312 study. 3. 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 the Entry Visit. Subjects should not initiate treatment with thiazolidinediones at any time during the study. 4. Subjects who have any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severly limit the subject's lifespan or ability to complete the study. Such conitions may include: hemodialysis or peritoneal dialysis, history of renal transplant, diagnosis or recurrence of malignancy, alcohol or drug abuse, disabling or terminal illness, mental disorders, or institutionalization by judicial order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety of darusentan in subjects with RHTN despite treatment with full doses of three or more antihypertensive medications, including a diuretic. ; Secondary Objective: Secondary objectives of this study are to examine the long-term efficacy of darusentan on SBP, DBP, mean 24-hour ambulatory BP, percent of subjects meeting SBP goal, and eGFR. ; Primary end point(s): The primary efficacy endpoints are change from baseline after 14 weeks of treatment in trough sitting SBP and DBP measured by sphygmomanometry. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Spain, United Kingdom
Outcome results
None listed