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

NCT03078907 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-03-30

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Thomas Pfister · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2020-02-10
Completion
2020-02-10
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Ireland
  • Norway
  • Portugal
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078907 on ClinicalTrials.gov