The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
392
Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
Amlodipine 5mg Daily oral administration for 8 weeks
Catholic University of Korea Bucheon St. Mary's Hospital
Wonmi-gu, Bucheon, South Korea
Change mean sitting Diastolic Blood Pressure (msDBP) at week 8 compared to baseline
Time frame: Week 8
Change mean sitting Diastolic Blood Pressure (msDBP) at week 4 compared to baseline
Time frame: Week 4
Change mean sitting Systolic Blood Pressure (msSBP) at week 4 and 8 compared to baseline
Time frame: Week 4 and 8
Proportion of patients achieving treatment goal at week 4 and 8: < 140/90 mmHg
Joint National Committee VII Guideline Treatment goal: \< 140/90 mmHg (\< 130/80 mmHg, diabetic or chronic renal failure patient)
Time frame: Week 4 and 8
Blood Pressure Response rate at week 4 and 8: msSBP reduction ≥ 20 mmHg and msDBP reduction ≥ 10 mmHg
Time frame: Week 4 and 8
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Amlodipine 10mg Daily oral administration for 8 weeks
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Kyungpook National University Hospital
Joong-gu, Daegu, South Korea
Daegu Catholic University Medical Center
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Dongguk University Ilsan Hospital
Ilsandong-gu, Goyang-si, Gyeoggi-do, South Korea
Chonnam National University Hospital
Dong-Gu, Gwangju, South Korea
Catholic University of Korea Uijeongbu St. Mary's hospital
Uijeongbu-si, Gyeoggi-do, South Korea
...and 13 more locations