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

ovartis Farmacéutica, S.A.0 个研究点目标入组 44 人开始时间: 2022年7月27日最近更新: 2024年4月29日

研究概览

暂无简介。

•- 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 screening)
•--> drug or toxin induced (for example, anorexigen or methamphetamine use)
•- Resting mean pulmonary arterial pressure > 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg as determined by right heart catheterization
•- Pulmonary Vascular Resistance > 6 Wood unites (480 dynes s/cm5), as determined by right heart catheterization
•- WHO Functional Class II-III
•- 6MWD must be between 150 and 550 m (inclusive).
•- Standard of care therapy which is stable at least 6 weeks prior to RHC and 6MWT assessment
•Other protocol-defined criteria may apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•- Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups that were not covered by the inclusion criteria.
•- 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 .
•Other protocol-defined criteria may apply.

发起方

ovartis Farmacéutica, S.A.