Candesartan Cilexetil Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,151
- 主要终点
- Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Hypertensive patients who meet all of the following conditions ([1] to [3]):
- •Patients receiving continuous therapy with Blopress Tablets
- •Patients aged < 20 years or ≥ 75 years
- •Patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance
研究组 & 干预措施
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)
干预措施: candesartan cilexetil (Drug)
结局指标
主要结局
Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)
时间窗: Baseline up to 3 years
SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants Reporting One or More Adverse Drug Reactions (ADR)
时间窗: Baseline up to 3 years
ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
次要结局
- Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities(Baseline up to 3 years)
- Incidence of Cerebrovascular/Cardiovascular Events(Baseline up to 3 years)
- Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities(Baseline up to 3 years)
- Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities(Baseline up to 3 years)