CTRI/2010/091/000645招募中4 期
An observational, multinational, multi-center, prospective, open-label study to assess effectiveness, safety and tolerability in patients with arterial hypertension receiving aliskiren or aliskiren HCT in a real-world setting
ovartis Healthcare Pvt. Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli , Mumbai - 400018. Ph: +91 22 2498 8888, Fax: +91 22 2495 41120 个研究点目标入组 1,500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients eligible for inclusion in this study have to fulfill the following criteria:
- •1. Male and female outpatients, aged ≥ 18 years with established diagnosis of hypertension, for whom treatment with aliskiren or aliskiren HCT is medically recommended.
- •2. Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care.
- •Aliskiren or aliskiren HCT can be administered as monotherapy, respectively SPC therapy (first antihypertensive treatment or switch from a previous treatment), or as add-on therapy and should be in adherence with the prescribing information (Summary of product characteristics).
- •Treatment with aliskiren or aliskiren HCT SPC is medically recommended for patients with established diagnosis of hypertension (DBP- 90mmHg and/or SBP- 140mmHg) under current antihypertensive medication, and/or unacceptable side effects caused by their current antihypertensive medication. For high risk patients with type 1 or 2 diabetes, best practice guidelines (10) recommend DBP<80mmHg and SBP<130mmHg, however we leave it to the prescribing physician to determine at which point to initiate treatment.
- •The indication for the administration of aliskiren or aliskiren HCT SPC, as well as contraindications and possible side effects have to be considered and can be taken from the Summary of Product Characteristics. The therapy shall not be prescribed for the purpose of entering a patient in this observational study, but solely based on clinical judgement of the treating physician.
排除标准
- •Contraindications mentioned in the local Summary of Product Characteristics for aliskiren or aliskiren HCT SPC
研究者
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