Zacras Combination Tablets LD & HD specified drug-use survey Long-term use survey
Not Applicable
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT1080222541
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 1090
Inclusion Criteria
Hypertensive patients
Exclusion Criteria
Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
[1] Patients with a history of hypersensitivity to any of the ingredients of Zacras Combination Tablets or other dihydropyridine drugs
[2] Patients who are pregnant or having possibilities of being pregnant
[3] Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse events<br>Primary timeframe: For 12 months<br>The frequencies of all adverse events observed during the observation period will be tabulated by type, time of onset, seriousness, and causal relationship to Zacras Combination Tablets. Adverse events are defined as any unfavorable and unintended all of signs (including abnormal test values), symptoms or diseases temporally associated with administration of azilsartan/amlodipine combination tablet, whether or not it was considered related to the treatment.
- Secondary Outcome Measures
Name Time Method Office blood pressure<br>Secondary timeframe: From baseline to 12 months of treatment<br>For the efficacy analysis set, the value of office blood pressure measurements, corresponding changes from baseline, and the rate of change from baseline at each assessment time point will be tabulated.