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NCT01560624 · ClinicalTrials.gov registry record · Phase 3

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

A Phase 3 study, sponsored by United Therapeutics.

Completed
Registry status
Phase 3
Development phase
690
Enrollment target

NCT01560624: Completed Phase 3 study, sponsored by United Therapeutics.

NCT01560624 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 690 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01560624, a Phase 3 study, has completed, sponsored by United Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
690 participants
Enrollment target

Study Summary

This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

Primary Outcome

Clinical worsening was assessed continuously from randomization until the subject's last study visit. Clinical worsening events were defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response. All clinical worsening events reported by the study sites were reviewed by the Sponsor Medical Monitors

Interventions

  • DRUG Placebo
  • DRUG Treprostinil Diolamine

Trial Details

FieldValue
Enrollment Target 690 participants
Start Date 2012-06-26
Est. Completion 2018-06-24
Phase Phase 3
United Therapeutics

63 total trials

What the finished NCT01560624 record still lists

NCT01560624 is an interventional study that assigns participants to a tested intervention. The registered 690 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower).

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

NCT01560624 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01560624 about?

NCT01560624 is a clinical study titled "Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy". This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

What is the current status of trial NCT01560624?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 690 participants. The study started on 2012-06-26. Estimated completion is 2018-06-24.

What interventions are being tested in trial NCT01560624?

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

Who is sponsoring clinical trial NCT01560624?

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

How this trial's enrollment target compares

Where NCT01560624's enrollment target sits among peer trials

690 524th of 2000 higher than 1,476 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01560624, the US trial registry maintained by the National Library of Medicine. NCT01560624 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.