Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,409
- Primary Endpoint
- Number of Participants Who Experience at Least One Adverse Events
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Candesartan cilexetil/Amlodipine besilate
8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily
Intervention: Candesartan cilexetil/Amlodipine besilate (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experience at Least One Adverse Events
Time Frame: Up to 12 Months
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Time Frame: Up to 12 Months
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.
Secondary Outcomes
- Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment(Baseline and final assessment (up to 12 Months))
- Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment(Baseline and final assessment (up to 12 Months))
- Changes From Baseline in Pulse Rate at Final Assessment(Baseline and final assessment (up to 12 Months))
- Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment(Baseline and final assessment (up to 12 Months))