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临床试验/NCT02242877
NCT02242877已完成不适用

Observational Study in Everyday Medical Practice of the Effectiveness of Telmisartan for Treatment of Isolated Systolic Hypertension in Comparison With Systolic/Diastolic Hypertension in Patients Aged 55 or Older

Boehringer Ingelheim0 个研究点目标入组 3,320 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
3,320
主要终点
Normalization of arterial systolic hypertension

研究概览

简要总结

The aim of this study is to compare the effect of treatment with telmisartan on patients in whom the systolic BP is approximately 12 weeks after starting treatment under control for the first time between patients with isolated systolic hypertension (ISH) at the beginning to patients with systolic/diastolic hypertension (SDH)

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

入选标准

  • Age ≥ 55, with no upper limit
  • Patient who has been treated and followed up for more than 12 months by the same general practitioner (GP)
  • Hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:
  • isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure < 90 mmHg or
  • systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg; or
  • systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmHg, if the patient has diabetes or chronic renal insufficiency
  • Treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
  • Decision by the GP to add telmisartan (either in combination with hydrochlorothiazide (HCTZ) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. The prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
  • Written informed consent of the patient to collect his/her data

排除标准

  • The patient refuses to allow his/her data to be collected
  • Change in the antihypertensive treatment during the month prior to collection of the data
  • Blood pressure under control
  • The recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/L or more are not collected in the context of this study

研究组 & 干预措施

Isolated systolic hypertension

干预措施: Telmisartan (Drug)

Isolated systolic hypertension

干预措施: Telmisartan combined with hydrochlorothiazide (Drug)

Systolic and diastolic hypertension

干预措施: Telmisartan (Drug)

Systolic and diastolic hypertension

干预措施: Telmisartan combined with hydrochlorothiazide (Drug)

结局指标

主要结局

Normalization of arterial systolic hypertension

时间窗: Up to 12 weeks after start of treatment

次要结局

  • Assessment of systolic blood pressure (SBP) response(Up to 12 weeks after start of treatment)
  • Mean decrease in systolic blood pressure(Up to 12 weeks after start of treatment)
  • Number of patients with adverse events(Up to 12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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