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NCT03626688 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

A Phase 3 study, sponsored by United Therapeutics.

Completed
Registry status
Phase 3
Development phase
687
Enrollment target

NCT03626688 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 687 participants.

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The verdict

NCT03626688, a Phase 3 study, has completed, sponsored by United Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
687 participants
Enrollment target

Study Summary

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Interventions

  • DRUG Placebo
  • DRUG Ralinepag

Trial Details

FieldValue
Enrollment Target 687 participants
Start Date 2019-01-24
Est. Completion 2025-12-31
Phase Phase 3

Sponsor

United Therapeutics

63 total trials

What the Registry Record Tells You About NCT03626688

The ClinicalTrials.gov registry entry for NCT03626688 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 687 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.

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

NCT03626688 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03626688 about?

NCT03626688 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients". Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

What is the current status of trial NCT03626688?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 687 participants. The study started on 2019-01-24. Estimated completion is 2025-12-31.

What interventions are being tested in trial NCT03626688?

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

Who is sponsoring clinical trial NCT03626688?

This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.

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

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.