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临床试验/NCT00613314
NCT00613314已完成不适用

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 15,268 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15,268
试验地点
1
主要终点
Response Rate at the End of 30 Day Period

研究概览

简要总结

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 45 years
  • Increased waist circumference (>88.9cm [>35in] men, >78.7cm [>31in] for women)
  • Elevated triglycerides (>150mg/dl)
  • Low HDL cholesterol (<40mg/dl in men, <50mg/dl in women)
  • Hypertension (>130/>85mmHG)
  • Impaired fasting glucose (>110mg/dl) (8)
  • Hypertensive patient assessed to benefit from telmisartan based treatment

排除标准

  • Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients
  • <3 months myocardial infarction (MI), stroke or severe heart failure

结局指标

主要结局

Response Rate at the End of 30 Day Period

时间窗: End of 30 day Period

Response rate of Blood Pressure assessed in the following categories: * Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline * Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Response Rate at the End of 60 Day Period

时间窗: At the end of 60 day period

Response rate on Blood Pressure: 1. Sitting SBP \< 130 mmHg and/or a reduction of \> 20 mmHg from baseline. 2. Sitting DBP \< 85 mmHg and/or a reduction of \> 10 mmHg from baseline. 3. Sitting BP normalization \< 130 mmHg and DBP \< 85 mmHg

Change in Systolic Blood Pressure (SBP) From Baseline

时间窗: Baseline and 60 days

Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Change in Diastolic Blood Pressure (DBP) From Baseline

时间窗: Baseline and 60 days

Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

次要结局

  • Percentage of Patients With Presence of Metabolic Risk Factor(At the end of 60 day period)

研究者

申办方类型
Industry

研究点 (1)

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