NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142592

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment26/6/2014
Target sample size1090
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Zacras Combination Tablets LD & HD (azilsartan/amlodipine) Dosage And administration of the intervention : For adults, one Zacras Combination Tablet (20 mg/2.5 mg [for LD Tablets] or 20 mg/5 mg [for HD Tablets] of azilsartan/amlodipine) is administered orally once daily. ZACRAS Combination Tablets should not be used as the first-line drug for the treatment of hypertension. Control intervention name : null

Outcome(s)

Primary OutcomeFrequency of adverse events Primary timeframe: For 12 months The frequencies of all adverse events observed during the observation period will be tabulated by type, time of onset, seriousness, and causal relationship to Zacras Combination Tablets. Adverse events are defined as any unfavorable and unintended all of signs (including abnormal test values), symptoms or diseases temporally associated with administration of azilsartan/amlodipine combination tablet, whether or not it was considered related to the treatment.
Secondary OutcomeOffice blood pressure Secondary timeframe: From baseline to 12 months of treatment For the efficacy analysis set, the value of office blood pressure measurements, corresponding changes from baseline, and the rate of change from baseline at each assessment time point will be tabulated.

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaHypertensive patients
Exclude criteriaHypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey: [1] Patients with a history of hypersensitivity to any of the ingredients of Zacras Combination Tablets or other dihydropyridine drugs [2] Patients who are pregnant or having possibilities of being pregnant [3] Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)

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/
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