A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag

Actelion Pharmaceuticals Ltd0 个研究点目标入组 20 人开始时间: 2017年2月14日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1. Signed informed consent prior to any study-mandated procedure.
•2. Male and female subjects at least 18 to 75 years inclusive.
•3. Subjects with PAH belonging to the Updated Clinical Classification Group 1
•4. Subjects who have been prescribed Uptravi® in compliance with local prescribing information (i.e., SmPC or USPI).
•5. Stable PAH defined as WHO Functional Class (FC) I-III at Visit 1 and Visit 2 and no change (i.e., introduction or dose change) in PAH-specific medication (i.e., ERA, PDE-5 inhibitor or sGC stimulator) and diuretics in the last 28 days prior to Visit 2.
•6. Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at least 28 days before Visit 2.
•7. A woman of childbearing potential is eligible only if she has a negative urine pregnancy test at Visit 1 and at Visit 2.
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. Pregnant, planning to become pregnant or lactating.
•2. Known and documented moderate or severe hepatic impairment.
•3. Subjects having received gemfibrozil at any time since initiation of Uptravi®.
•4. Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit 1.
•5. SBP < 90 mmHg at Visit 1 or at Visit 2.
•6. Known or suspected uncontrolled hyperthyroidism.
•7. Severe renal failure and ongoing or planned dialysis.
•8. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. This
•includes subjects for whom participation in the study might be associated with excessive stress, in the opinion of the investigator.
•9. Known concomitant life-threatening disease with a life expectancy < 12 months.
•10. Treatment with another investigational treatment within 3 months of Visit 1.

发起方