Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01560624
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2012-03-09
Brief Title:
Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Phase III International Multi-Center Randomized Double-Blind Placebo-Controlled Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy
Status:
COMPLETED
Status Verified Date:
2020-02
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:
FREEDOM-EV
Brief Summary:
This is an international multicenter randomized double-blind placebo-controlled event driven study in subjects with pulmonary arterial hypertension
Detailed Description:
Study TDE-PH-310 is an international multicenter randomized 11 oral treprostinil UT-15C placebo double-blind placebo-controlled study in subjects with pulmonary arterial hypertension PAH who are receiving background oral monotherapy for PAH for at least 30 days at randomization Subjects are randomly allocated to receive oral treprostinil extended-release tablets or placebo by a stratified randomization by type of background therapy Strata 1 phosphodiesterase type 5 inhibitor PDE5-I or soluble guanylate cyclase sGC stimulator Strata 2 endothelin receptor antagonist ERA Subjects are also stratified by baseline 6-minute walk distance 6MWD less than or equal to 350 m or greater than 350 m Subjects receive their first dose of study drug 0125 mg or matching placebo on the day of randomization Oral dosing of study drug is continued at 0125 mg 3 times daily TID every 6 to 8 hours with food The dose or matching placebo is titrated throughout the study up to a maximum dose of 12 mg TID to reach and maintain a tolerated dosing regimen that provided optimal clinical benefit Once randomized subjects return for study visits every 4 weeks for the first 12 weeks then every 12 weeks for the duration of the study Subjects continue in the study until experiencing clinical worsening the number of adjudicated events necessary for study closure occurr or prematurely discontinue participation in the study for any reason other than protocol-specified clinical worsening At each scheduled visit subjects undergo efficacy assessments for clinical worsening exercise capacity 6MWD and Borg dyspnea score WHO functional class FC and plasma N-Terminal pro-brain natriuretic peptide NT-proBNP Subjects could participate in an optional hemodynamic sub-study assessed by RHC Safety assessments consist of adverse events AEs physical examinations vital signs 12-lead electrocardiograms ECGs and clinical laboratory parameters Patients who complete all required assessments are eligible to enter a long-term open-label extension study TDE-PH-311
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None