NIPH Clinical Trials Search

JAPIC ID: JapicCTI-142466

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment03/3/2014
Target sample size300
Countries of recruitment
Intervention(s)Intervention name : Azilva Tablets (azilsartan) Dosage And administration of the intervention : The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg. Control intervention name : null


Primary OutcomeChanges from baseline in blood pressure measured at the medical institution and at home Primary timeframe From baseline to 24 weeks Summary statistics of measured values and respective changes from baseline will be calculated at each time point
Secondary Outcome[1] Changes from baseline in pulse rate measured at the medical institution [2] Changes from baseline in HbA1c (National Glycohemoglobin Standardization Program [NGSP] value) [3] Changes from baseline in urinary albumin level (creatinine-adjusted value)[4] Frequency of adverse events Secondary timeframe [1-3] From baseline to 24 weeks [4] 24 weeks [1-3] Summary statistics of measured values and respective changes from baseline will be calculated at each test time point. [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.

Key inclusion & exclusion criteria

Age minimum
Age maximum
Include criteriaPatients 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).
Exclude criteriaPatients with contraindications to azilsartan

Related Information


public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
scientific contact
Name Takeda Pharmaceutical Company Limited Post Marketing Surveillance, Pharm(continued to "Affiliation")
Affiliation acovigilance Department, Takeda Development Center Japan