Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

Takeda

Status: Completed

Conditions: Hypertension

Treatments: Drug: candesartan cilexetil

Study type: Observational

Funder types: Industry

Identifiers

NCT02166697

JapicCTI-142567 (Registry Identifier)

460-015

JapicCTI-R160847 (Registry Identifier)

Details and patient eligibility

About

The purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

Full description

This survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (Blopress Tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

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.

Enrollment: 14,151 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Hypertensive patients with at least one of the following risk factors:

• Waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female
• Fasting triglyceride level ≥ 150 milligram per deciliter (mg/dL)
• High-density lipoprotein (HDL) cholesterol level less than (<) 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

Exclusion Criteria: Hypertensive 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

Trial design

14,151 participants in 1 patient group

Oral administration of 4-8 mg of candesartan cilexetil

Description:

Oral administration of 4-8 milligram (mg) of candesartan cilexetil once daily (increased up to 12 mg, as necessary)

Treatment:

Drug: candesartan cilexetil