A Phase III Long-term Study of TAK-536TCH in Participants With Essential Hypertension

Inclusion Criteria

• In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
• The participant has essential hypertension.
• The participant has an office sitting systolic blood pressure (SBP) of <180 mmHg and office sitting diastolic blood pressure (DBP) of < 110 mmHg at the start of the run-in period (Week -4). Participants receiving combined therapy with a 3-drug antihypertensive within 4 weeks prior to the start of the run-in period is required to have an office sitting SBP of < 160 mmHg and an office sitting DBP of < 100 mmHg.
• The participant's office sitting blood pressure at Week -2 and at the end of the run-in period (Week 0) need to be either:
• Participants without concurrent diabetes mellitus or chronic kidney disease (CKD)*: Sitting SBP of ≥ 140 mmHg or sitting DBP of ≥ 90 mmHg
• Participants with concurrent diabetes mellitus or CKD*: Sitting SBP of ≥ 130 mmHg or sitting DBP of ≥ 80 mmHg.
• Estimate glomerular filtration rate according to creatinine (eGFRcreat) of <60 mL/min/1.73 m^2, or urinary albumin (spot urine) of ≥30 μg/mL in laboratory tests performed at Week -2 of the run-in period, and diagnosed with CKD by the investigator or subinvestigator.
• The participant has an office sitting SBP of < 160 mmHg and office sitting DBP of < 100 mmHg at the end of the run-in period (Week 0).
• The participant is male or female, aged 20 years or older at the time of providing informed consent.
• The participant is an outpatient.
• A female participant of childbearing potential who is sexually active with a nonsterilized male partner agree to use routinely adequate contraception from signing of informed consent through 1 month following the end of the study.

Exclusion Criteria

• The participant has received any study drugs within 12 weeks prior to the start of the run-in period.
• The participant has participated in another clinical study or a post-marketing study within 30 days prior to the start of the run-in period.
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g. spouse, parent, child, sibling), or may consent under duress.
• The participant requires taking prohibited concomitant drugs during the study.
• The participant has a history of hypersensitivity or allergies to TAK-536, AML, HCTZ, any thiazide diuretic or analog, any dihydropyridine drug, or any analog of TAK-536TCH.
• The participant is judged by the investigator or subinvestigator to be in danger of experiencing an excessive increase in blood pressure when changing or discontinuing premedication.
• The participant received combination therapy with antihypertensive drugs of the 3 ingredients contained in TAK-536TCH.
• The participant received combined therapy with antihypertensive drugs, including 4 or more components, within 4 weeks prior to the start of the run-in period.
• The participant has secondary or malignant hypertension.
• The participant has a difference of ≥ 20 mmHg between left and right arms in office sitting SBP at the start of the run-in period (Week -4).
• The participant has apparent white coat hypertension or exhibits a white coat effect.
• . The participant has a day-night reversed lifestyle, such as those working during the night.
• The participant has sleep apnea syndrome requiring treatment.
• The participant has any of the following cardiovascular diseases:
• Cardiac disease: Myocardial infarction*, coronary arterial revascularization*, severe valvular disorder, atrial fibrillation, any of the following conditions requiring treatment: angina pectoris, congestive heart failure, arrhythmia
• Cerebrovascular disorders: Cerebral infarction/cerebral hemorrhage*, transient ischem