NL-OMON53913尚未招募2 期
An open-label extension study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension - CLTP001A12201E1
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 3
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Participant is currently completing the Novartis-sponsored study
- •CLTP001A12201 in PAH and completed key efficacy and safety procedures up to the
- •end of treatment of the parent study, without
- •meeting discontinuation criteria in the parent study.
- •Willingness and ability to comply with scheduled visits, treatment plans and
- •any other study procedures.
- •Participant currently has no evidence of treatment failure, as determined by
- •the investigator, following previous treatment.
- •In the opinion of the Investigator the participant would benefit from LTP001
排除标准
- •History of hypersensitivity to the study treatment.
- •Required or planned transplant or heart/lung surgery.
- •Acute or chronic impairment (other than dyspnea), which would limit the
- •ability to comply with study requirements, including interference with physical
- •activity or execution of study procedures such as 6MWT (e.g., angina pectoris,
- •claudication, musculoskeletal disorder, need for
- •walking aids).
- •Permanent discontinuation of Novartis drug in the parent study due to
- •toxicity or disease progression, non-compliance to study procedures, withdrawal
- •of consent or any other reason.
研究者
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