CTRI/2022/04/042308进行中（未招募）4 期
An open label, observational, practice based, non-comparative, multicenter, prospective, active surveillance to evaluate the safety and tolerability of Bosentan 62.5mg/125mg oral tablets in patients with Pulmonary Arterial Hypertension (PAH) [WHO Group I].
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Cipla Ltd
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. A written, signed, dated and ethics committee approved
- •informed consent form (data sharing consent) from patient
- •and/or legally acceptable representatives
- •2. Either male or female of age 12 years and above
- •3. Patient with the confirmed diagnosis of PAH (Group I)
- •with WHO Class III to IV symptoms
排除标准
- •1. Contraindications to Bosentan or any of its components
- •2. Hypersensitivity to Bosentan or any of its components
- •3. Pregnancy and/or breastfeeding
- •4. Co-administration of drugs such as Cyclosporine A or
研究者
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