JPRN-jRCT2080220734UnknownPhase 3
Phase 3 study of TAK-536 (confirmatory trial)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 630
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •Key criteria for inclusion:
- •1. Grade I or II essential hypertension
- •2. Both sitting systolic and diastolic blood pressures at two time points (Week -2 and Week 0) during the screening period meet the following criteria:
- •Sitting systolic blood pressure: greater than or equal to 150 mmHg and less than 180 mmHg
- •Sitting diastolic blood pressure: greater than or equal to 95 mmHg and less than 110 mmHg
- •3. Both sexes. Twenty years or older at the time of informed consent
- •4. Able to understand the content of the study and comply with the study
- •5. Able to give informed consent in writing before participating in the study
- •6. Women with childbearing potential (premenopausal or non-sterilized woman) who agree to practice appropriate contraception from the screening period through the duration of the study
- •7. Therapeutic category during the screening period: Ambulatory
Exclusion Criteria
- •Key criteria for exclusion:
- •1. Secondary hypertension, grade III hypertension (sitting systolic blood pressure greater than or equal to 180 mmHg or sitting diastolic blood pressure greater than or equal to 110 mmHg), or malignant hypertension
- •2. The following circulatory-related diseases or symptoms:
- •(1) Cardiac disease: myocardial infarction (onset within 24 weeks before start of the screening period); coronary artery revascularization (performed within 24 weeks before start of the screening period); valvular stenosis; atrial fibrillation; the following diseases requiring medication: angina pectoris, congestive heart failure or arrhythmia
- •(2) Cerebrovascular disorder: cerebral infarction, cerebral hemorrhage (onset within 24 weeks before start of the screening period), transient ischemic attack (onset of an attack within 24 weeks before start of the screening period)
- •(3) Vascular disease: arteriosclerosis obliterans with symptoms of intermittent claudication, etc.
- •(4) Progressive hypertensive retinopathy: hemorrhage, exudation, or papilledema (observed within 24 weeks after start of the screening period)
- •3. Decrease in sitting diastolic blood pressure by 8 mmHg or more at 4 weeks after start of the screening period (Week 0) compared to 2 weeks after start of the screening period (Week -2)
- •4. Day/night reversal, e.g., nightshift worker
- •5. Clinically apparent hepatic impairment (e.g., with AST and ALT values of 2.5 x upper limit of normal or higher during the screening period)
- •6. Clinically apparent renal impairment (e.g., with serum creatinine value of 2.0 mg/dL or higher during the screening period)
- •7. Hyperkalemia (with a laboratory value of 5.5 mEq/L or higher during the screening period)
- •8. Malignant tumor
- •9. Compliance with the study drug of less than 80% during the screening period
- •10. Prior history of TAK-536 administration as study drug
- •11. History of hypersensitivity or allergy to candesartan cilexetil (Blopress tablets) and related drugs (ARB, ACE inhibitors, and renin inhibitors)
- •12. History of drug abuse (defined as illegal drug use) or alcohol dependency within 2 years before start of the screening period
- •13. Requirement of the excluded treatment
- •14. Pregnant or lactating women
- •15. Participation in another clinical trial or post-marketing clinical trial within 3 months before start of the screening period
Investigators
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