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NCT03888365 · ClinicalTrials.gov registry record
Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH
A clinical trial, sponsored by United Therapeutics.
- Completed
- Registry status
- 43
- Enrollment target
NCT03888365: Completed study, sponsored by United Therapeutics.
NCT03888365 is a clinical trial that has completed, run by United Therapeutics. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03888365 has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study 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.
Primary Outcome
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the I
Interventions
- DRUG Treprostinil
- DRUG Non-Treprostinil PAH Medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2019-09-19 |
What the finished NCT03888365 record still lists
NCT03888365 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Treprostinil is the first listed.
NCT03888365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03888365 about?
NCT03888365 is a clinical study titled "Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH". 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 measur...
What is the current status of trial NCT03888365?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2019-04-01. Estimated completion is 2019-09-19.
What interventions are being tested in trial NCT03888365?
The interventions under investigation include: Treprostinil (DRUG), Non-Treprostinil PAH Medications (DRUG).
Who is sponsoring clinical trial NCT03888365?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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