Overview

Azilsaltan Tablets (Azilva Tablets) Special Drug Use Surveillance "Hypertension Complicated by Diabetes "

Status:
Completed
Trial end date:
2016-02-29
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Treatments:
Azilsartan medoxomil
Criteria
Inclusion Criteria:

- Patients with hypertension who meet all the following criteria will be enrolled:

1. Patients who has complications of diabetes mellitus

2. 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)

3. 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

4. Patients who is an outpatient

5. 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