N/A
Completed N=1,090
Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
Source: ClinicalTrials.gov NCT02181816 ↗Enrolled (actual)
1,090
Serious AEs
1.6%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Events — 8.34 Percentage of Participants
Summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Events |
8.34 | — |
| SECONDARY Systolic Office Blood Pressure |
149.5; 137.2; 133.0 | — |
| SECONDARY Diastolic Office Blood Pressure |
83.3; 77.4; 75.0 | — |
Eligibility Criteria
Inclusion Criteria
-Hypertensive patients
Exclusion Criteria
-Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
- Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
- Patients who are pregnant or having possibilities of being pregnant
- Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
Data sourced from ClinicalTrials.gov (NCT02181816). 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.