ECARD Combination Tablets LD&HD special drug use surveillance: Long-term use (12 months)
Not Applicable
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT1080222313
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
Post-marketing surveillance
Exclusion Criteria
(1) Patients with a history of hypersensitivity to ingredients of ECARD LD&HD combination tablets, thiazides, or their analogues (e.g. sulphonamide derivatives such as chlortalidone)
(2) Patients with anuria or patients under hemodialysis
(3) Patients with acute renal failure
(4) Patients with noticeably decreased Na and K levels in body fluids
(5) Pregnant women or women planning to become pregnant
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse drug reactions<br>Primary timeframe 12 months<br>The frequency of adverse drug reactions by type, seriousness, time to onset. 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 the study drug are defined as adverse drug reactions.
- Secondary Outcome Measures
Name Time Method Changes from baseline in blood pressure<br>Secondary timeframe 12 months from the baseline<br>Calculation of summary statistics for actual measured values and the change from baseline in systolic/diastolic blood pressure. Tabulation of frequency of adverse drug reactions