Clinical trial NCT02166697: Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
Official title: Candesartan Cilexetil Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 14151
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions (ADR)
timeFrame: Baseline up to 3 years
measure: Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: Incidence of Cerebrovascular/Cardiovascular Events
timeFrame: Baseline up to 3 years
measure: Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities
timeFrame: Baseline up to 3 years
measure: Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities
timeFrame: Baseline up to 3 years
measure: Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: