Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration,
currently approved for the treatment of essential hypertension in Corea and Mexico. As the
safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to
address the potential for ethnic factors to have an effect on the drug´s efficacy and safety
in the Mexican population. To address this need, a cohort of 272 Mexican subjects with grades
1-2 essential hypertension were sequentially treated on a treat to target basis (target:
sitting Diastolic Blood Pressure (sDBP) <90 mmHg) with 60 mg FMS once a day (8 weeks), either
120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment period) and 120
mg FMS once a day (during 12 weeks) for a total treatment period of 24 weeks.