A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension. - CLTP001A12201

ovartis0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

研究概览

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•History of PAH belonging to one of the following subgroups of the Clinical
•Classification Group 1 (WHO):
•- Participants with idiopathic pulmonary arterial hypertension (IPAH)
•- Hereditary pulmonary arterial hypertension
•- Congenital heart disease (surgically repaired at least 12 months prior to
•- drug or toxin induced (for example, anorexigen, or methamphetamine use).
•-Resting mean pulmonary arterial pressure (mPAP) > 25 mmHg; pulmonary capillary
•wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg, as
•determined by right
•heart catheterization within 20 days of randomization.
•- Pulmonary Vascular Resistance > 6 Wood units (480 dynes s/cm-5), as
•determined by right heart catheterization within 20 days of randomization.
•- WHO Functional Class II-III
•- 6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to
•be within 20 days of randomization. To meet the above criterion additional six
•minute walk test (6MWT) may be performed up to a maximum of 3 tests in total
•prior to dosing; the minimal time difference between two tests should be at
•- Standard of care therapy which is stable at least 6 weeks prior to RHC and
•qualifying 6MWT assessment within 20 days of randomization.

•- Participants with pulmonary hypertension (PH) in the Clinical Classification
•Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion
•Criterion #4.
•- Participants with a history of left sided heart disease, chronic left sided
•heart failure, congenital or acquired valvular disease compromising left
•ventricular function and/or pulmonary venous hypertension or symptomatic
•coronary disease
•- Participants with obstructive lung disease defined as: FEV1/FVC < 60% and
•FEV1 < 60% of predicted value after bronchodilator administration as well as
•participants with moderate or severe
•restrictive lung disease: Total Lung Capacity < 70% of predicted value.
•- Acute or chronic impairment (other than dyspnea), which would limit the
•ability to comply with study requirements, including interference with physical
•activity and execution of study procedures such as 6MWT (e.g., angina pectoris,
•claudication, musculoskeletal disorder, multiple
•sclerosis, need for walking aids).

发起方