CClinicalTrials.gg
Sign In
WithdrawnNCT01557647INTREPIDUpdated Mar 26, 2012

Safety and Efficacy of Inhaled Treprostinil in Patients With PAH

A Phase 3 interventional study of Inhaled treprostinil and Placebo in Pulmonary Arterial Hypertension, sponsored by United Therapeutics. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-26.

Sponsored by United Therapeutics · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the effect of inhaled treprostinil compared to placebo on exercise capacity and time to clinical worsening.

02

Conditions studied

  • Pulmonary Arterial Hypertension
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

United Therapeutics is the lead sponsor of 81 studies on the registry; 6 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Eligible subjects must:

  • Be between 18 and 75 years of age at Screening (as defined by date of informed consent is signed),
  • Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary shunts (at least 1 year since repair) or human immunodeficiency virus (HIV) infection, or PAH associated with appetite suppressant or toxin use.
  • Be treatment naïve, or receiving background PAH therapies (e.g., phosphodiesterase type-5 inhibitor (PDE-5i)and / or endothelin receptor antagonist (ERA)) for less than 1 year prior to Screening.
  • Have a 6MWD at Baseline (as measured by the mean value of two 6MWT separated by at least 24 hours, but no more than 14 days) that is between 150 - 500 meters, inclusive.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    inhaled treprostinil

    Drug: Inhaled treprostinil

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugInhaled treprostinil

    0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.

  • DrugPlacebo

    placebo inhalation solution

06

What researchers measure

Primary outcomes

  1. Six-minute walk test

    Time frame: 6 months

Secondary outcomes

  1. Time to clinical worsening

    Time frame: 1 day to 2.5 years.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01557647
Lead sponsor
United Therapeutics
Responsible party
Sponsor
First posted
Mar 19, 2012
Start date
Jun 2012
Primary completion
Dec 2015 (estimated)
Completion
Jun 2016 (estimated)
Last update
Mar 26, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pulmonary Arterial Hypertension→

Other studies from this sponsor

United Therapeutics

Start the discussion