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临床试验/NCT00283036
NCT00283036已完成4 期

Efficacy and Tolerability of Posology Adaptation of Irbesartan in Ambulatory Hypertensive Patients

Sanofi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Sanofi
入组人数
200
试验地点
1
主要终点
Arterial Tension

研究概览

简要总结

Study objective : To compare efficacy and tolerability of posology adaptation of Irbesartan in ambulatory Hypertensive patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patient with mild or moderate hypertension defined with arterial diastolic pressure (PAD) at sit position between 90 mmHg and 110 mmHg and arterial systolic pressure (PAS) at sit position between 140 mmHg and 180 mmHg.
  • •Patient diagnosed after 3 consultations within 2 months who has never been under treatment and responding to the required conditions for hypertension treatment with irbesartan. This patient must has been under proper but insufficient hygieno dietetic diet
  • •Patient who has been under a none satisfied antihypertensive treatment, and for whom this treatment was stopped at least 2 weeks prior to inclusion.
  • •Patient with a laboratory analysis (urinary sediment- Na -K- creatinine, total cholesterol) and ECG during the month prior to inclusion.

排除标准

  • •Severe Hypertension defined by PAS > 180mmHg and/or PAD > 110 mmHg.
  • •Isolated systolic Hypertension
  • •Secondary Hypertension
  • •Arterial stenosis on unique kidney - arterial bilateral kidney stenosis
  • •Non-surgically sterilized women or non-menopaused women.
  • •Confirmed sodic depletion.
  • •Hypersensitivity to Irbesartan.
  • •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

结局指标

主要结局

Arterial Tension

Tolerability

次要结局

未报告次要终点

研究者

发起方
Sanofi
申办方类型
Industry

研究点 (1)

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