Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147199
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2005-09-02
Brief Title:
Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
TRIUMPH I Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIUMPH
Brief Summary:
This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension The primary outcome is the change in 6-minute walk distance from baseline to week 12
Detailed Description:
Patients who have been on a stable dose of 125 mg twice daily bid of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo
Administration of study medication was performed by inhalation with the OPTINEB ultrasonic nebulizer
The proposed dosing regimen was four times daily-upon awakening at midday evening dinner time and bedtime
After a patient has completed the twelve-week study period they were given the option of enrolling into an open-label extension study
Administration of study medication was performed by inhalation with the OPTINEB ultrasonic nebulizer
The proposed dosing regimen was four times daily-upon awakening at midday evening dinner time and bedtime
After a patient has completed the twelve-week study period they were given the option of enrolling into an open-label extension study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None