Ignite Creation Date:
2024-05-05 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00760916
Status:
WITHDRAWN
Last Update Posted:
2013-01-30
First Post:
2008-09-25
Brief Title:
FREEDOM DR Oral Treprostinil in Combination With an Endothelin Receptor Antagonist ERA andor a Phosphodiesterase-5 PDE-5 Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
FREEDOM DR An International Multi-Center 12-Week Double Blind Randomized Placebo-Controlled Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy Safety and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped prior to subject enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inhibitoror as a monotherapy treatment Study visits will occur at 4 week intervals for 12 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 At the end of the first 12-weeks the patient will be un-blinded Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label extension phase study FREEDOM - EXT
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label extension phase study FREEDOM - EXT
Detailed Description:
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 inhibitoror as a monotherapy treatment Study visits will occur at 4 week intervals for 12 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 At the end of the first 12-weeks the patient will be un-blinded Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label extension phase study FREEDOM - EXT
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label extension phase study FREEDOM - EXT
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