Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325442
Status:
COMPLETED
Last Update Posted:
2017-08-02
First Post:
2006-05-11
Brief Title:
FREEDOM-C Oral Treprostinil in Combination With an Endothelin Receptor Antagonist ERA andor a Phosphodiesterase-5 PDE-5 Inhibitor for the Treatment of Pulmonary Arterial Hypertension PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A 16-Week International Multicenter Double-Blind Randomized Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist andor a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
This study was an international multi-center randomized double-blind placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH ie endothelin receptor antagonist andor phosphodiesterase-5 inhibitor Study visits occurred at 4 week intervals for 16 weeks the key measure of efficacy was the 6-minute walk test Study procedures included routine blood tests medical history physical exams disease evaluation and exercise tests One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16
Patients who completed all assessments for 16-weeks were also eligible to enter an open-label extension phase study FREEDOM - EXT
Patients who completed all assessments for 16-weeks were also eligible to enter an open-label extension phase study FREEDOM - EXT
Detailed Description:
None
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