nisia Combination Tablets LD, HD Special Drug Use Surveillance Hypertension: Long-Term Use
Not Applicable
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT1080222340
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
hypertensive patients
Exclusion Criteria
Patients in whom Unisia Combination Tablets are contraindicated.
[Contraindications]
(1) Patients with a history of hypersensitivity to the ingredients of the drug or other dihydropyridines
(2) Women who are pregnant or of child-bearing potential
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse events and adverse drug reactions<br>Primary timeframe 12 months from the baseline<br>Frequency, severity, and time to onset of adverse events and adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
- Secondary Outcome Measures
Name Time Method Changes in blood pressure, achievement rate of the target blood pressure levels<br>Secondary timeframe 12 months from baseline<br>Calculation of summary statistics for actual measurement values and the change from baseline in systolic and diastolic blood pressure.