Azilva Tablets special drug use surveillance Hypertension complicated by diabetes

Not Applicable

• Conditions: Hypertension

• Registration Number: JPRN-jRCT1080222416
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 300

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 subject enrollment and will continue such treatment until the first administration of Azilva Tablets)
[3] Patients who has a systolic blood pressure of >= 130 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, subject enrollment will be performed in two divided steps: Step-1 (at the first hospital visit before prescription of Azilva Tablets) and Step-2 (at the time of prescription of Azilva Tablets).

Exclusion Criteria

Patients with contraindications to azilsartan

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline in blood pressure measured at the medical institution and at home<br>Primary timeframeFrom baseline to 24 weeks<br>Summary statistics of measured values and respective changes from baseline will be calculated at each time point

Secondary Outcome Measures

Name	Time	Method
[1] Changes from baseline in pulse rate measured at the medical institution<br>[2] Changes from baseline in HbA1c (National Glycohemoglobin Standardization Program [NGSP] value)<br>[3] Changes from baseline in urinary albumin level (creatinine-adjusted value)[4] Frequency of adverse events<br>Secondary timeframe<br>[1-3] From baseline to 24 weeks<br>[4] 24 weeks<br>[1-3] Summary statistics of measured values and respective changes from baseline will be calculated at each test time point.<br>[4] The frequency of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of azilsartan, whether or not it was considered related to the treatment.