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NCT02583789 · ClinicalTrials.gov registry record · Early Phase 1

Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon

A Early Phase 1 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Early Phase 1
Development phase
12
Enrollment target

NCT02583789 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants.

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The verdict

NCT02583789, a Early Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjects will be randomized to receive oral treprostinil sustained release tablets or matching placebo for 12 weeks and then crossover for 12 weeks. All subjects will be exposed for 12 weeks of treatment with oral UT-15C during the study.

Interventions

  • DRUG Placebo
  • DRUG oral treprostinil

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2016-05
Est. Completion 2021-12-31
Phase Early Phase 1

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT02583789

The ClinicalTrials.gov registry entry for NCT02583789 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02583789 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02583789 about?

NCT02583789 is a clinical study titled "Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon". This study represents the first trial to assess the efficacy of oral treprostinil therapy in patients with symptomatic primary or secondary Raynaud's Phenomenon (RP) resistant to vasodilatory therapy. The study will be randomized 1:1 UT-15C to placebo. The design is a crossover study and all subjec...

What is the current status of trial NCT02583789?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2016-05. Estimated completion is 2021-12-31.

What interventions are being tested in trial NCT02583789?

The interventions under investigation include: Placebo (DRUG), oral treprostinil (DRUG).

Who is sponsoring clinical trial NCT02583789?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.