NCT03078907

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

Detailed description

This study is designed as exploratory with the purpose to generate hypotheses on new endpoints

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Selexipag	Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.
DRUG	Placebo	Matching film coated tablets

Timeline

• Start date: 2017-11-08
• Primary completion: 2020-02-10
• Completion: 2020-02-10
• First posted: 2017-03-14
• Last updated: 2025-03-30
• Results posted: 2021-02-23

Locations

39 sites across 10 countries: United States, Austria, France, Germany, Ireland, Norway, Portugal, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study