CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Treprostinil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03888365
NCT03888365N/ACompleted

An Observational Study to Characterize Patient Global Impression Questions for Activity-induced Symptoms in Patients With Pulmonary Arterial Hypertension (PAH)

United Therapeutics·observational·Posted Mar 25, 2019·Updated Mar 16, 2021

In Brief

An observational study evaluating Treprostinil and Non-Treprostinil PAH Medications for Pulmonary Arterial Hypertension. Completed, enrolled 43 participants across 10 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartApr 1, 2019
Primary CompletionSep 19, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.3 years ago

Interventions

Treprostinildrug

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

Non-Treprostinil PAH Medicationsdrug

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