N/A
Completed N=387
Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
Source: ClinicalTrials.gov NCT02100319 ↗Enrolled (actual)
387
Serious AEs
1.4%
Results posted
Mar 2019
Primary outcomePrimary: Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution — -10.5; -5.1 Millimeter of Mercury (mmHg)
Summary
The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution |
-10.5; -5.1 | — |
| PRIMARY Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24) |
-7.9; -4.1; -7.1; -4.3 | — |
| SECONDARY Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution |
-1.3 | — |
| SECONDARY Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution |
6.72 | — |
| SECONDARY Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution |
-44.344 | — |
| SECONDARY Percentage of Participants Who Had One or More Adverse Events |
6.47 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hypertension who meet all the following criteria will be enrolled:
- Patients who has complications of diabetes mellitus
- Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
- Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
- Patients who is an outpatient
- Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.
*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).
Exclusion Criteria
- Patients with contraindications to azilsartan
Data sourced from ClinicalTrials.gov (NCT02100319). 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.