Back to resultsInhaled Treprostinil for PAH: Open-label Extension (INTREPID - OL)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
inhaled treprostinil
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
Participation and completion of all required visits for study RIN-PH-302.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inhaled treprostinil
Arm Description
Outcomes
Primary Outcome Measures
Long term safety of inhaled treprostinil
Secondary Outcome Measures
Six-minute walk distance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01557660
Brief Title
Inhaled Treprostinil for PAH: Open-label Extension
Acronym
INTREPID - OL
Official Title
Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open-label extension of RIN-PH-302.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inhaled treprostinil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
inhaled treprostinil
Intervention Description
0.6mg/mL inhalation solution, up to 12 breaths four times a day
Primary Outcome Measure Information:
Title
Long term safety of inhaled treprostinil
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Six-minute walk distance
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participation and completion of all required visits for study RIN-PH-302.
12. IPD Sharing Statement
Learn more about this trial
Inhaled Treprostinil for PAH: Open-label Extension
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