NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142441

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment20/6/2012
Target sample size3000
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Azilva Tablets (azilsartan) Dosage And administration of the intervention : The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patients' age and condition. The maximum daily dose is 40 mg. Control intervention name : null

Outcome(s)

Primary OutcomeFrequency of adverse drug reactions Primary timeframe 12 months The frequencies of all adverse drug reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended all of signs, symptoms or diseases temporally associated with administration of azilsartan,whether or not it was considered related to the treatment. Among these, events which are considered to have a casual relationship with azilsartan are defined as adverse drug reactions.
Secondary OutcomeChange in blood pressure Secondary timeframe From baseline to 12 months Tabulation of actual measured value and changes from baseline at each test time point in blood pressure (test value at each test time point after baseline - test value at baseline)

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteria1. Patients with a history of hypersensitivity to any of the ingredients of in azilsartan. 2. Patients who are pregnant or having possibilities of being pregnant
Exclude criteria

Related Information

Contact

public contact
Name Takeda Pharmaceutical Company Limited Contact for Clinical Trial Information
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation
scientific contact
Name Takeda Pharmaceutical Company Limited Post Marketing Surveillance, Pharmacovigilance Department
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation