跳至主要内容
临床试验/NCT00946829
NCT00946829已完成不适用

Study of Hypertensive Population Under Treatment With Micardis in Real Clinical Conditions With the Goal to Control the Early Morning BP Rise

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 18,299 人开始时间: 2003年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
18,299
试验地点
1
主要终点
Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).

研究概览

简要总结

The aim of the observational study is to ascertain the degree of blood pressure control in the early-morning hours after 8 weeks of treatment with Telmisartan/Telmisartan+Hydrochlorothiazide and during 44 weeks of follow-up, in patients with hypertension using home blood pressure measurements.

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

入选标准

  • Patients with mild to moderate essential hypertension and whose medical condition make them eligible for treatment with Telmisartan/Telmisartan+HCTZ

排除标准

  • Pre-menopausal women who had had no birth control, who are pregnant or nursing
  • Patients with advanced hepatic impairment, advanced renal impairment or both
  • Patients with functional class III or IV (NYHA) congestive heart failure (CHF), unstable angina, acute myocardial infarction, heart surgery or stroke within the previous six months
  • Patients with any valvular disease with hemodynamic repercussion
  • Patients receiving chronic administration of oral anticoagulants or digoxin
  • Patients with known hypersensitivity to any component in the formulation of Micardis / MicardisPlus
  • Patients with previous history of angioedema associated with ACE inhibitors
  • Patients with severe, uncontrolled hypertension or any form of secondary hypertension
  • Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol

结局指标

主要结局

Change from baseline in mean early morning systolic blood pressure, mean early morning diastolic blood pressure, and degree of control. (6:00 to 11:59), BP < 135/85 mmHg. (HBPM: mean of morning measurements).

时间窗: 217 Weeks

次要结局

  • Clinical control (office BP), response rates, reduction in office cuff systolic and diastolic BP. Office BP control criteria: BP < 140/90 mmHg. Pulse rate, pulse pressure, discontinuations and tolerability.(217 Weeks)

研究者

申办方类型
Industry

研究点 (1)

Loading locations...

相似试验