Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Selexipag
Product Code: ACT-293987
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Selexipag
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Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: NA;Timepoint(s) of evaluation of this end point: Over Period 1, Period 2 and Period 3 combined;Main Objective: The primary objective of this study is to assess whether temporary switching from a stable oral dose of selexipag to an intravenous (i.v.) dose of selexipag providing comparable exposure to active metabolite ACT-333679 and switching back to the initial oral dose of selexipag is safe and well tolerated in subjects with stable pulmonary arterial hypertension (PAH).; Primary end point(s): Main safety variables are: - Proportion of discontinuations due to prostacyclin-associated adverse events (AEs) - Proportion of AEs and serious AEs - Proportion of prostacyclin-associated AEs - Proportion of AEs related to injection site reactions - Proportion of PAH-related AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Germany, United States
Contacts
Public ContactClinical Trial Disclosure Desk
Actelion Pharmaceuticals Ltd
Outcome results
None listed