Ignite Creation Date:
2024-05-05 @ 9:27 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00887978
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2009-04-23
Brief Title:
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A 16-Week International Multicenter Double-Blind Randomized Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2012-12
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:
FREEDOM-C2
Brief Summary:
This study is an international multi-center randomized double-blind placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH ie endothelin receptor antagonist andor phosphodiesterase-5 inhibitor Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test Study procedures include routine blood tests medical history physical exams disease evaluation and exercise tests
Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label extension phase study FREEDOM - EXT
Patients who complete all assessments for 16-weeks will also be 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