NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142567

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment07/6/2006
Target sample size15000
Countries of recruitment
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Blopress Tablets (candesartan cilexetil) Dosage And administration of the intervention : For adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. The dose is increased up to 12 mg, as necessary. For patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg. Control intervention name : null

Outcome(s)

Primary OutcomeIncidence of cerebrovascular/cardiovascular events Primary timeframe: 3 years from baseline If a cerebrovascular/cardiovascular event occurs, the physicians in charge of the surveillance should enter the following information in the "cerebrovascular/cardiovascular events survey form:" (i) rationale for diagnosing, (ii) onset date, (iii) seriousness and the rationale for the assessment of seriousness, (iv) causality between the event and Blopress Tablets, (v) treatment of the event, (vi) assessment date of outcome, and (vii) outcome, when completing the survey form. <Cerebrovascular/cardiovascular events> - Sudden death - Cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage - Acute myocardial infarction, hospitalization due to heart failure, intervention for angina pectoris or hospitalization due to angina pectoris, or atrial fibrillation - Transition to dialysis, or renal transplantation - Dissecting aortic aneurysm - Diabetic retinopathy - New onset of diabetes mellitus
Secondary OutcomeFrequency of adverse drug reactions Secondary timeframe: Up to 3 years The frequencies 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 candesartan cilexetil whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with candesartan cilexetil are defined as adverse drug reactions.

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaHypertensive patients with at least one of the following risk factors: - Waist circumference >= 85 cm for male and >= 90 cm for female - Fasting triglyceride level >= 150 mg/dL - High-density lipoprotein (HDL) cholesterol level < 40 mg/dL - Fasting blood glucose level >= 110 mg/dL - Body-mass index (BMI) >= 25.0 *Patients currently taking medications for hypertriglyceridemia, hypo-HDL-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance
Exclude criteriaHypertensive patients who meet all of the following conditions ([1] to [3]): [1] Patients receiving continuous therapy with Blopress Tablets [2] Patients aged < 20 years or >= 75 years [3] Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance

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, Pharm(continued to &quot;Affiliation&quot;)
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation acovigilance Department, Pharmaceutical Development Division