The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.
This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension. This study consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
353
TAK-536CCB 20 mg/5 mg +Hydrochlorothiazide placebo tablets
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets
TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets
Unnamed facility
Touon-shi, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Hiroshima, Hiroshima, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Change from Baseline in the office trough sitting diastolic blood pressure (DBP)
Change in the office trough sitting DBP from the end of the placebo run-in period (baseline \[Week 0\]) to the end of the treatment period (Week 10, last observation carried forward \[LOCF\])
Time frame: Baseline and Week 10
Change from Baseline in the office trough sitting systolic blood pressure (SBP)
Change in the office trough sitting SBP from the end of the placebo run-in period (baseline \[Week 0\]) to the end of the treatment period (Week 10, last observation carried forward \[LOCF\])
Time frame: Baseline and Week 10
Proportion of patients achieving < 140/90 mmHg
Patients achieving \< 140/90 mmHg refer to those meeting both of the following criteria: * A decrease to \< 90 mmHg in office trough sitting DBP * A decrease to \< 140 mmHg in office trough sitting SBP
Time frame: 10 weeks
Proportion of responders (140/90 mmHg criterion)
Patients who met either of the following conditions are regarded as responders (140/90 mmHg criterion). * A ≥ 20 mmHg decrease in office trough sitting SBP and a ≥ 10 mmHg decrease in the office trough sitting DBP * A decrease to \< 140 mmHg in office trough sitting SBP and a decrease to \< 90 mmHg in office trough sitting DBP
Time frame: 10 weeks
Frequency of adverse events( including vital sign, body weight, ECG findings and laboratory tests)
The frequency of adverse events by type, seriousness. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug
Time frame: 10 weeks
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TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2
TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2
Unnamed facility
Hanamaki-shi, Iwate, Japan
Unnamed facility
Morioka, Iwate, Japan
Unnamed facility
Kumamoto, Kumamoto, Japan
Unnamed facility
Kyoto, Kyoto, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Osaka, Osaka, Japan
...and 3 more locations
Time profile of office trough sitting diastolic blood pressure
Time frame: 10 weeks
Time profile of office trough sitting systolic blood pressure
Time frame: 10 weeks