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Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH

NCT03888365 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2021-03-16

Study results available
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Summary

This is an observational, multicenter, single-day, Phase 2 study. This study will include a 14-day Screening Period and Study Day 1 clinic visit. Participants will be required to perform an activity to induce symptoms of PAH, and participants' severity of self-reported symptoms of PAH will be measured from pre-activity, immediately after the activity, and through the 30-minute recovery. Participants will be asked about their PAH symptoms using 3 PGI-S questions that address their overall PAH symptoms, shortness of breath, and physical fatigue.

Conditions

Interventions

DRUG

Treprostinil

Treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.

DRUG

Non-Treprostinil PAH Medications

Non-treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.

Sponsors & Collaborators

  • Lung Biotechnology PBC

    collaborator INDUSTRY

  • United Therapeutics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-19
Completion
2019-09-19

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03888365 on ClinicalTrials.gov