Candesartan Cilexetil/Amlodipine Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"|
- Frequency of adverse events and adverse drug reactions [ Time Frame: 12 months from the baseline ]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..
- Changes in blood pressure, achievement rate of the target blood pressure levels [ Time Frame: 12 months from baseline ]Calculation of summary statistics for actual measurement values and the change from baseline in systolic and diastolic blood pressure.
|Study Start Date:||June 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
8 mg/2.5 mg or 8 mg/5 mg, orally, once daily
Drug: Candesartan cilexetil/amlodipine
Candesartan cilexetil/amlodipine tablets
Other Name: Unisia Combination Tablets
This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine combination tablets (Unisia Combination Tablets) in patients with hypertension in the routine clinical setting.
The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine) administered orally once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068495
|Study Chair:||Postmarketing Group Manager||Takeda|