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

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. Identifier: NCT01557660
Recruitment Status : Withdrawn
First Posted : March 19, 2012
Last Update Posted : March 26, 2012
Information provided by (Responsible Party):
United Therapeutics

Brief Summary:
Open-label extension of RIN-PH-302.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: inhaled treprostinil Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: inhaled treprostinil Drug: inhaled treprostinil
0.6mg/mL inhalation solution, up to 12 breaths four times a day

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Participation and completion of all required visits for study RIN-PH-302.

Responsible Party: United Therapeutics Identifier: NCT01557660     History of Changes
Other Study ID Numbers: RIN-PH-303
First Posted: March 19, 2012    Key Record Dates
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