N/A
Completed N=3,437
Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Source: ClinicalTrials.gov NCT02092025 ↗Enrolled (actual)
3,437
Serious AEs
0.3%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) — 94 Participants
Summary
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) |
94 | — |
| SECONDARY Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point |
-15.4; -19.8 | — |
| SECONDARY Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point |
-7.7; -10.3 | — |
Eligibility Criteria
Inclusion Criteria
- Hypertensive patients
Exclusion Criteria
- Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
- Patients who are pregnant or having possibilities of being pregnant
Data sourced from ClinicalTrials.gov (NCT02092025). 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.