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临床试验/NCT01219556
NCT01219556已完成不适用

Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension.

Bayer0 个研究点目标入组 8,704 人开始时间: 2010年11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
发起方
Bayer
入组人数
8,704
主要终点
Changes in seated diastolic pressure

研究概览

简要总结

This is post-marketing observational study in which data on safety and effectiveness of Xirtam H will be collected from routine clinical practice. The study objectives are to investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure > 140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study. The routine investigation suggested by the attending physician will be done in patients of hypertension. No additional investigation will be done for the study purpose. The patient not controlled on existing treatment and prescribed Xirtam H will be included in study after taking the informed consent. The patient will be followed up for 2-follow up visit each after 6 weeks. The physical examination, routine investigation, blood pressure measures will be done and the data will be entered in the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604 patients from around 300 - 350 trial sites in India.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Indian hypertensive patients (Blood pressure > 140/90 mm Hg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study.

排除标准

  • Exclusion criteria must be read in conjunction with corresponding product prescribing information

研究组 & 干预措施

Group 1

干预措施: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105) (Drug)

结局指标

主要结局

Changes in seated diastolic pressure

时间窗: 12 weeks

Changes in seated systolic pressure

时间窗: 12 weeks

Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)

时间窗: 12 weeks

次要结局

  • Number of patients with adverse events as measure of safety(12 weeks)
  • Percentage of patients with satisfaction to treatment(12 weeks)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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