Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01266265 · ClinicalTrials.gov registry record

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

A clinical trial of Pulmonary Arterial Hypertension, sponsored by United Therapeutics.

Completed
Registry status
1,333
Enrollment target
20
Study locations

NCT01266265: Completed study of Pulmonary Arterial Hypertension, sponsored by United Therapeutics.

NCT01266265 is a study of Pulmonary Arterial Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 1,333 participants, above the 441-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (202% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01266265, a study of Pulmonary Arterial Hypertension, has completed, sponsored by United Therapeutics.

COMPLETED
Registry status
1,333 participants
Enrollment target
20
Study locations

Study Summary

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

Primary Outcome

Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

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
United Therapeutics

63 total trials

What the finished NCT01266265 record still lists

NCT01266265 is an observational study that tracks outcomes without assigning an intervention. Its 1,333 participants enrollment target places it among the larger protocols in the corpus, above the 441-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (202% higher).

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.

NCT01266265 names 20 study sites across 5 states, led by California, Florida, Alabama.

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.

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).

Who is sponsoring clinical trial NCT01266265?

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

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.

Similar trials for Pulmonary Arterial Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01266265's enrollment target sits among peer trials

1,333 5th of 63 higher than 59 of 63 other Pulmonary Arterial Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT05415761 · 1,332 participants · NA

    Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

  • NCT05511298 · 1,332 participants

    Empowering Students Project

  • NCT06934876 · 1,332 participants

    Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

  • NCT06972056 · 1,335 participants · Phase 4

    Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01266265, the US trial registry maintained by the National Library of Medicine. NCT01266265 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.