Candesartan Cilexetil/Amlodipine Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
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|ClinicalTrials.gov Identifier: NCT02068495|
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : February 21, 2014
|Condition or disease||Intervention/treatment|
|Hypertension||Drug: Candesartan cilexetil/amlodipine|
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.
|Study Type :||Observational|
|Actual Enrollment :||3409 participants|
|Official Title:||Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068495
|Study Chair:||Postmarketing Group Manager||Takeda|