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

NCT ID: NCT02166697

Last Updated: 2016-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral administration of 4-8 mg of candesartan cilexetil

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

candesartan cilexetil

Intervention Type DRUG

candesartan cilexetil tablets

Interventions

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candesartan cilexetil

candesartan cilexetil tablets

Intervention Type DRUG

Other Intervention Names

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Blopress Tablets

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Postmarketing Group Manager

Role: STUDY_CHAIR

Takeda

Other Identifiers

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JapicCTI-142567

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-R160847

Identifier Type: REGISTRY

Identifier Source: secondary_id

460-015

Identifier Type: -

Identifier Source: org_study_id

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