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Inhaled Treprostinil for PAH: Open-label Extension (INTREPID - OL)

This study has been withdrawn prior to enrollment.
ClinicalTrials.gov Identifier:
First Posted: March 19, 2012
Last Update Posted: March 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
Open-label extension of RIN-PH-302.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: inhaled treprostinil Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Long term safety of inhaled treprostinil [ Time Frame: up to 5 years ]

Secondary Outcome Measures:
  • Six-minute walk distance [ Time Frame: up to 5 years ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled treprostinil Drug: inhaled treprostinil
0.6mg/mL inhalation solution, up to 12 breaths four times a day


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Participation and completion of all required visits for study RIN-PH-302.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01557660     History of Changes
Other Study ID Numbers: RIN-PH-303
First Submitted: March 14, 2012
First Posted: March 19, 2012
Last Update Posted: March 26, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents