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NCT01105117 · ClinicalTrials.gov registry record · Phase 4

Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401

A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Actelion.

Completed
Registry status
Phase 4
Development phase
2
Enrollment target
7
Study locations

NCT01105117 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Actelion. The registered enrollment target is 2 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT01105117, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Actelion.

COMPLETED
Registry status
Phase 4
Development phase
2 participants
Enrollment target
7
Study locations

Study Summary

This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

Interventions

  • DRUG ACT-385781A (Actelion Epoprostenol)
  • DRUG Flolan®

Study Locations (7)

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • Baylor College of Medicine - Houston

California

  • University of California - San Diego - La Jolla

Colorado

  • University of Colorado - Denver - Aurora

North Carolina

  • Duke University Medical Center - Durham

Pennsylvania

  • University of Pennsylvania-Penn Presybyterian Medical Center - Philadelphia

Tennessee

  • Vanderbilt Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2010-05
Est. Completion 2011-12
Phase Phase 4

Sponsor

Actelion

63 total trials

What the Registry Record Tells You About NCT01105117

The ClinicalTrials.gov registry entry for NCT01105117 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (100% lower). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which ACT-385781A (Actelion Epoprostenol) is the first listed.

NCT01105117 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01105117 about?

NCT01105117 is a clinical study titled "Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401". This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

What is the current status of trial NCT01105117?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2010-05. Estimated completion is 2011-12.

What conditions does trial NCT01105117 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT01105117?

The interventions under investigation include: ACT-385781A (Actelion Epoprostenol) (DRUG), Flolan® (DRUG).

Who is sponsoring clinical trial NCT01105117?

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

Where is trial NCT01105117 being conducted?

This trial has 7 study locations across California, Colorado, North Carolina, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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