Phase 3 study of TAK-536 (confirmatory trial)
- Conditions
- Essential hypertension
- Registration Number
- JPRN-jRCT2080220734
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 630
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough sitting diastolic blood pressure (change from end of the screening period to end of the treatment period)
- Secondary Outcome Measures
Name Time Method <Efficacy><br>Trough sitting diastolic blood pressure (change from end of the screening period to Week 8 of the treatment period); Trough sitting systolic blood pressure (change from end of the screening period to Week 8 of the treatment period); Trough sitting diastolic and systolic blood pressures at each evaluation; responder rate; rate of patients with normalized blood pressure; evaluation by ABPM (1: 24-hour trend of diastolic and systolic blood pressures and pulse rate , 2: mean change in diastolic and systolic blood pressures and pulse rate [for 24 hours, daytime, and nighttime], 3: Trough/Peak ratio of diastolic and systolic blood pressures, 4: Hyperbaric Index of diastolic and systolic blood pressures)<br><Safety><br>Adverse event, laboratory tests, vital sign (sitting pulse rate), body weight, resting 12-lead ECG