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.
This was a prospective, open, multicentre, 24 week study of subjects with grade 1-2 essential hypertension eligible, according to the participating investigator's clinical judgement, to initial monotherapy. Consenting, eligible subjects at 13 Mexican participating centers were initially assigned to monotherapy with 60 mg FMS once a day. At treatment week 8, those subjects with a sDBP ≥90 mmHg were randomized to either 120 mg FMS or to 60 mg FMS + 12.5 mg hydrochlorothiazide (HCTZ) once a day during 4 weeks. At treatment week 12, all non-responding subjects were finally assigned to 120 mg FMS + 12.5 mg HCTZ for the remaining 12 weeks of the planned 24 week treatment period. At treatment weeks 8 and 12, those subjects with a sDBP \< 90 mmHg remained on their assigned treatment for the rest of the study. This cohort study was designed to collect information on treatment effect (blood pressure changes from baseline/reference time and treatment response rates), and safety (i.e., incidence and characterization of clinical, laboratory and ECG adverse events); accordingly, subjects were assessed at treatment weeks 4, 8, 12, 16, 20 and 24 in terms of vital signs, clinical laboratory safety parameters, concomitant medications and adverse events. 12-lead ECG recordings were obtained from all subjects both at screening and at treatment week 24 and a subset of 11 subjects underwent both baseline and treatment week 8 24-hour ABPM recordings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Fimasartan tablets
Fimasartan plus hydrochlorothiazide fixed dose combination tablets
Hospital de Jesús IAP
México, D.f., Mexico
Hospital General de Ticomán
México, D.f., Mexico
Centro Médico Exel
Tijuana, Estado de Baja California, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Unidad de Investigación Clínica Cardiometabólica de Occidente
Guadalajara, Jalisco, Mexico
Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Icle S.C.
Guadalajara, Jalisco, Mexico
Núcleo Médico La Paz
Guadalajara, Jalisco, Mexico
Hospital Dr. Ángel Leaño
Zapopan, Jalisco, Mexico
Instituto Jalisciense de Investigación en Diabetes y Obesidad S. C.
Guadalajara, Jalsico, Mexico
...and 3 more locations
Blood Pressure Change From Baseline
Treatment Week 8 mean sDBP and sitting Systolic Blood Pressure (SBP) changes from baseline (all study subjects treated with 60 mg FMS once a day)
Time frame: Baseline to Treatment Week 8
Blood Pressure Change from Week 8
Treatment Week 12 mean sDBP and sSBP changes from week 8 on subjects randomized to either 120 mg FMS or 60 mg FMS + 12.5 mg HCTZ once a day
Time frame: Treatment Week 8 to Treatment Week 12
Week 8 Treatment Response Rate
Proportion of subjects with sDBP \< 90 mmHg at treatment week 8 (all subjects treated with 60 mg FMS once a day)
Time frame: Baseline to Treatment Week 8
Week 12 Treatment Response Rate
Proportion of subjects with sDBP \< 90 mmHg at treatment week 12 (subjects randomized to either 120 mg FMS or 60 mg FMS + 12.5 mg HCTZ once a day)
Time frame: Treatment Weeks 8 to 12
Blood Pressure Change from Week 12
Treatment Week 24 mean sDBP and sSBP changes from treatment week 12 (subjects assigned at treatment week 12 to 120 mg FMS + 12.5 mg HCTZ
Time frame: Treatment Weeks 12 to 24
Week 24 Treatment Response Rate
Proportion of non-responding subjects assigned at treatment week 12 to 120 mg FMS + 12.5 mg HCTZ with sDBP \< 90 mmHg at Treatment Week 24
Time frame: Treatment Weeks 12 to 24
Adverse Event Incidence
Incidence and characterization of clinical, laboratory and ECG adverse events observed in all subjects assigned to treatment in the study receiving at least one dose of the study medications
Time frame: Baseline to Treatment Week 24
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