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
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