Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325403
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2006-05-11
Brief Title:
FREEDOM - M Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A 12-Week International Multicenter Double-Blind Randomized Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2013-02
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 multicenter randomized 21 activeplacebo double-blind placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH Study visits occurred at 4 week intervals for 12 weeks with an additional visit at Week 11 with the key measure of efficacy being the 6-minute walk test Study procedures included routine blood tests medical history physical exams disease evaluation and exercise tests Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12
Patients who completed all assessments for 12 weeks were also eligible to enter an open-label extension phase study FREEDOM - EXT
Patients who completed all assessments for 12 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