INTREPID - OL: Inhaled Treprostinil for PAH: Open-label Extension
Sponsor
United Therapeutics (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01557660
Collaborator
(none)
0
1
78
Study Details
Study Description
Brief Summary
Open-label extension of RIN-PH-302.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
N/A
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
:
Jun 1, 2012
Anticipated Primary Completion Date
:
Dec 1, 2018
Anticipated Study Completion Date
:
Dec 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: inhaled treprostinil
|
Drug: inhaled treprostinil
0.6mg/mL inhalation solution, up to 12 breaths four times a day
|
Outcome Measures
Primary Outcome Measures
- Long term safety of inhaled treprostinil [up to 5 years]
Secondary Outcome Measures
- Six-minute walk distance [up to 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Participation and completion of all required visits for study RIN-PH-302.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- United Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01557660
Other Study ID Numbers:
- RIN-PH-303
First Posted:
Mar 19, 2012
Last Update Posted:
Mar 26, 2012
Last Verified:
Mar 1, 2012
Additional relevant MeSH terms: