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COMPLETED Phase 4

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

NCT01105117 · View on ClinicalTrials.gov ↗

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

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01105117

The ClinicalTrials.gov registry entry for NCT01105117 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01105117 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01105117?

The interventions under investigation include: ACT-385781A (Actelion Epoprostenol) (DRUG), Flolan® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01105117?

This trial is sponsored by Actelion, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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