Selexipag for Pulmonary Arterial Hypertension

(SALTO Trial)

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Actelion

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Research Team

Actelion Clinical Trial

Principal Investigator

Actelion

Eligibility Criteria

This trial is for children aged 2-18 with Pulmonary Arterial Hypertension (PAH) who are already on stable PAH treatment. They must weigh at least 9 kg and have a confirmed diagnosis through right heart catheterization. It's not for those with certain types of PAH, previous selexipag use, life-threatening diseases, or pregnancy.

Inclusion Criteria

I have been on a stable dose of treatment for pulmonary arterial hypertension for at least 3 months.

I am between 2 and 18 years old and weigh at least 9 kilograms.

I have pulmonary arterial hypertension (PAH) and may also have Down syndrome.

Exclusion Criteria

I have a serious illness and am expected to live less than a year.

You are allergic or very sensitive to selexipag or its ingredients.

Pregnant, planning to become pregnant, or lactating

Treatment Details

Interventions

• Placebo (Drug)
• Selexipag (Prostacyclin Receptor Agonist)

Trial Overview The study tests if adding Selexipag to standard treatments can slow down the progression of PAH in children compared to a placebo. Participants will be randomly assigned to receive either Selexipag or a placebo alongside their current treatment.

Participant Groups

Group I: Selexipag Experimental Treatment 1 Intervention

Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing.

Who Is Running the Clinical Trial?

Actelion

Lead Sponsor

Trials

192

Recruited

35,500+

Jean-Paul Clozel

Actelion

Chief Executive Officer since 1997

MD from University of Basel

Martine Clozel

Actelion

Chief Medical Officer since 1997

MD from University of Geneva