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

Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: candesartan cilexetil (Drug)

Phase: N/A

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Postmarketing Group Manager, Study Chair, Affiliation: Takeda

Summary

The purpose of this survey is 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 (e. g., visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

Clinical Details

Official title: Candesartan Cilexetil Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Incidence of cerebrovascular/cardiovascular events

Secondary outcome: Frequency of adverse drug reactions

Detailed 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 (e. g., 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.

Eligibility

Minimum age: 20 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Hypertensive 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 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

Locations and Contacts

Additional Information

Starting date: June 2006
Last updated: June 16, 2014

Page last updated: August 20, 2015

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