N/A
Completed N=3,409
Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Source: ClinicalTrials.gov NCT02068495 ↗Enrolled (actual)
3,409
Serious AEs
1.9%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants Who Experience at Least One Adverse Events — 286 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Events |
286 | — |
| PRIMARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
85 | — |
| SECONDARY Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment |
-14.6 | — |
| SECONDARY Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment |
-7.2 | — |
| SECONDARY Changes From Baseline in Pulse Rate at Final Assessment |
-1.2 | — |
| SECONDARY Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment |
28.5; 66.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02068495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.