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临床试验/NCT00982735
NCT00982735已完成不适用

An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice.

Boehringer Ingelheim0 个研究点目标入组 987 人开始时间: 2007年9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
987
主要终点
Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.

研究概览

简要总结

The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female.
  • Aged 20 to 80 years old.
  • Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg).
  • Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

排除标准

  • Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
  • Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
  • Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
  • Patients participating in any other protocol

结局指标

主要结局

Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.

时间窗: 24 weeks

次要结局

  • Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion(24 weeks)
  • Change From Baseline in Microalbuminuria at 24 Weeks(Baseline and 24 weeks)

研究者

申办方类型
Industry

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