Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance Hypertension: Long-Term Use

Study Overview
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Brief Summary
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The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.

Detailed Description
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This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants 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 besilate) administered orally once daily.

Official Title
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Unisia Combination Tablets LD, HD Special Drug Use Surveillance Hypertension: Long-Term Use

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Candesartan cilexetil/Amlodipine besilate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Participants with hypertension Exclusion Criteria: Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated [Contraindications] Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations Women who are pregnant or of child-bearing potential
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candesartan cilexetil/Amlodipine besilate<br>8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily | Drug: Candesartan cilexetil/Amlodipine besilate<br>* Candesartan cilexetil/Amlodipine besilate tablets<br>* Other names: Unisia Combination Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience at Least One Adverse Events |  | Up to 12 Months | 
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs 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. | Up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment | Reported data are changes in SBP from baseline at final assessment (up to 12 months). | Baseline and final assessment (up to 12 Months) | 
| Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment | Reported data are changes in DBP from baseline at final assessment (up to 12 months). | Baseline and final assessment (up to 12 Months) | 
| Changes From Baseline in Pulse Rate at Final Assessment | Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months). | Baseline and final assessment (up to 12 Months) | 
| Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment | Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg. | Baseline and final assessment (up to 12 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy