Essential hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-536TCH, TAK-536CCB, hydrochlorothiazide
INN of investigational material :
Therapeutic category code : 214 Antihypertensives
Dosage and Administratio
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2.The participant signs and dates an informed consent form prior to the initiation of any study procedures. 3.The participant has essential hypertension. 4.The participant's clinic sitting systolic blood pressure (SBP) is Sitting SBP is >= 140 mmHg or sitting DBP is >= 90 mmHg Sitting SBP is >= 130 mmHg or sitting DBP is >= 80 mmHg 6.The participant's clinic sitting SBP is < 160 mmHg and clinic sitting DBP is < 100 mmHg at the end of the run-in period (Week 0). 7.Sex: male and/or female; Aged 20 years or older at the time when informed consent is obtained. 8.Hospitalization status: Outpatient 9.A female participant of childbearing potential who are sexually active with a nonsterilized male partner agree to use routinely adequate contraception from signing of informed consent to 1 month after the end of the study.
Exclusion criteria
Exclusion criteria: 1.The participant has received any investigational compounds within 12 weeks prior to the start of the run-in period. 2.The participant has participated in other clinical trials or post-marketing studies within 30 days prior to the start of the run-in period. 3.The participant is an immediate family member, study site employee, or is in a dependant 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. 4.The participant requires treatment with a prohibited concomitant drug during the study. 5.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. 6.The participant may, in the opinion of the investigator or subinvestigator, experience an excessive increase in blood pressure when changing or discontinuing premedication. 7.The participant previously received treatment with a three-ingredient antihypertensive drug with the same three ingredients found in TAK-536TCH. 8.The participant received therapy with 4 or more different antihypertensive agents within 4 weeks prior to the start of the run-in period. 9.The participant has secondary or malignant hypertension. 10.The participant's clinic sitting SBP at Week -4 differs between left and right arms by >= 20 mmHg. 11.The participant has apparent white coat hypertension or shows a white coat effect. 12.The participant leads a nocturnal lifestyle due to working a night shift or for another reason. 13.The participant has sleep apnea syndrome requiring treatment. 14.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 disorders when drug treatment is required: angina pectoris, congestive heart failure, arrhythmia - Cerebrovascular disorders: Cerebral infarction/cerebral hemorrhage, transient ischemic attack - Vascular disease: Peripheral artery disease with intermittent claudication, artery dissection, aneurysm - Advanced hypertensive retinopathy: With bleeding or exudate/papilledema 15.The participant has a clinically apparent hepatic disorder (e.g., alanine aminotransferase (AST) or aspartate aminotransferase (ALT) at Week -2 of the run-in period >= 2.5 times the upper limit of normal). 16.The participant has a clinically severe renal disorder (e.g., eGFRcreat in laboratory tests performed at Week -2 of run-in period = 7.4% in laboratory tests performed at Week -2 of run-in period). 20.The participant has a malignancy. 21.If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.. 22.The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the start of the run-in period. 23.The participant is otherwise found ineligible by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse events Primary timeframe Up to 52 weeks The frequencies of all adverse events will be tabulated. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinic blood pressure - Home blood pressure Secondary timeframe Up to 52 weeks The change from baseline to the each evaluation point of treatment period in clinic trough sitting systolic and diastolic blood pressure, and home sitting systolic and diastolic blood pressure on awakening and at bedtime. | — |
Outcome results
None listed