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Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

NCT01266265 · View on ClinicalTrials.gov ↗

Study Summary

A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

Interventions

  • DRUG inhaled prostacyclin
  • DRUG prostacyclin
  • DRUG subcutaneous and intravenous prostacyclin
  • DRUG oral ERA

Study Locations (20)

California

  • Berkeley Cardiovascular Medical Group — Berkeley
  • Cedars-Sinai Heart Institute — Beverly Hills
  • University California San Francisco — Fresno
  • University of Southern California — Los Angeles
  • West Los Angeles VA Healthcare Center — Los Angeles
  • University of California Davis Medical Center — Sacramento
  • University of California, San Francisco — San Francisco
  • Paloma Medical Group — San Juan Capistrano
  • Santa Barbara Cottage Hospital — Santa Barbara
  • Stanford Hospital and Clinics — Stanford

Florida

  • St. Francis Sleep Allergy & Lung — Clearwater
  • University of Florida — Gainesville
  • Pulmonary and Critical Care Associates — Jacksonville
  • University of Florida College of Medicine Jacksonville — Jacksonville

Alabama

  • Cardiovascular Associates, P.C. — Birmingham
  • The University of Alabama at Birmingham — Birmingham
  • University of South Alabama — Mobile

Colorado

  • Children's Hospital Denver — Denver
  • Western States Clinical Research, Inc. — Wheat Ridge

Arizona

  • Arizona Pulmonary Specialists, LTD — Phoenix

Trial Details

FieldValue
Enrollment Target 1,333 participants
Start Date 2010-12
Est. Completion 2014-12

Sponsor

United Therapeutics

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01266265

The ClinicalTrials.gov registry entry for NCT01266265 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 1,333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 67 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 4 interventions — of which inhaled prostacyclin 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: NCT01266265 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT01266265 about?

NCT01266265 is a clinical study titled "Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies". A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

What is the current status of trial NCT01266265?

This trial is currently completed. The enrollment target is 1,333 participants. The study started on 2010-12. Estimated completion is 2014-12.

What conditions does trial NCT01266265 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 NCT01266265?

The interventions under investigation include: inhaled prostacyclin (DRUG), prostacyclin (DRUG), subcutaneous and intravenous prostacyclin (DRUG), oral ERA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01266265?

This trial is sponsored by United Therapeutics, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01266265 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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