Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03187678
• Date of registration: 09/06/2017
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
• Scientific title: 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
• Date of first enrolment: December 4, 2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03187678
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany, United States

Contacts

• Name: Ralph Preiss
• Affiliation: Actelion

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent form prior to any study-mandated procedure.

- Male and female subjects aged from 18 to 75 years (inclusive),

- Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional
Class 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.

- Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at
least 28 days before Visit 2.

- Women of childbearing potential must have a negative pregnancy test at Visit 1
(screening) and Visit 2.

Exclusion Criteria:

- Pregnant, planning to become pregnant or lactating.

- Known and documented moderate or severe hepatic impairment.

- Subjects having received gemfibrozil at any time since initiation of Uptravi®.

- Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit
1.

- SBP < 90 mmHg at Visit 1 or at Visit 2.

- Known or suspected uncontrolled hyperthyroidism.

- Severe renal failure and ongoing or planned dialysis.

- Any known factor or disease that might interfere with treatment compliance, study
conduct, or interpretation of the results.

- Known concomitant life-threatening disease with a life expectancy < 12 months.

- Treatment with another investigational treatment within 3 months of Visit 1.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: i.v. selexipag

Drug: oral selexipag (Uptravi)

Primary Outcome(s)

Number of Participants With Prostacyclin-associated Adverse Events [Time Frame: From Day 1 to Day 37]

Number of Participants With Adverse Event Related to Injection Site Reactions [Time Frame: From Day 2 to Day 3]

Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation [Time Frame: From Day 2 to Day 3]

Number of Participants With at Least One Adverse Event (AE) [Time Frame: From Day 1 to Day 37]

Number of Participants With PAH-related Adverse Events [Time Frame: From Day 1 to Day 37]

Secondary ID(s)

2016-004035-21

AC-065A309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03187678