Ignite Creation Date:
2024-05-06 @ 3:22 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02279160
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2014-10-25
Brief Title:
Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Placebo-controlled Phase 2 Trial of Ralinepag an Oral IP Receptor Agonist in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2020-06
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:
The study was conducted as a placebo-controlled randomized 22-week double-blind study which included a dose titration period An additional transition period occurred for those patients who elected to enroll into the open-label extension study APD811-007 A total of 61 patients with PAH were enrolled
Detailed Description:
Study APD811-003 was a 22-week randomized double-blind parallel-group placebo-controlled study in subjects with symptomatic WHO Group 1 PAH The study consisted of a dose titration period of up to 9 weeks a 13-week maintenance period and a follow-up visit that was to occur approximately 3 weeks after the end of the maintenance period Week 25 The transition period of 3 weeks 1 week was to occur for those subjects who elected to enroll into the open-label extension OLE Study APD811-007
Approximately 60 subjects with PAH were planned to be enrolled 61 actual After screening eligible subjects were randomized 21 to ralinepag APD811 or to placebo Randomization was stratified by baseline WHONYHA functional class II versus III or IV Subjects randomized to active therapy were given ralinepag at a starting dose of 001 mg BID Subjects randomized to the placebo arm received matching placebo capsules to preserve the blind Subjects were instructed to take the study drug ralinepag or placebo with food Dosage was then uptitrated as tolerated over the course of the 9-week dose-titration period to a maximum dose of 03 mg BID Although doses could be reduced based on tolerability the final dosage reached was required to be stable during the 13-week treatment period prior to evaluation at Week 22
Subjects could receive concomitant oral disease-specific PAH therapy consisting of an ERA andor an agent acting on the nitric oxide pathway a PDE-5 inhibitor or a sGC stimulator provided the dose had remained stable for at least 3 months prior to the start of screening It was recommended that subjects continue the same dose and regimen of these medications for the duration of the study With the exception of prostanoids the use of other supporting therapies which may affect PAH was also permitted
During the study assessments of efficacy were performed including PVR and other hemodynamic parameters as determined by RHC the 6MWT assessment of clinical worsening BNP and NT-proBNP levels WHONYHA functional class assessment of PAH Safety assessments included standard evaluations of AEs clinical laboratory values vital signs and ECG measurements
At the end of the maintenance period subjects who did not choose to participate in the OLE study were to discontinue study drug ralinepag or placebo All subjects that chose to continue in the OLE study were to remain on study drug until the follow-up visit at Week 25 This visit served as the baseline visit for the OLE study if the subject was eligible and chose to participate
Approximately 60 subjects with PAH were planned to be enrolled 61 actual After screening eligible subjects were randomized 21 to ralinepag APD811 or to placebo Randomization was stratified by baseline WHONYHA functional class II versus III or IV Subjects randomized to active therapy were given ralinepag at a starting dose of 001 mg BID Subjects randomized to the placebo arm received matching placebo capsules to preserve the blind Subjects were instructed to take the study drug ralinepag or placebo with food Dosage was then uptitrated as tolerated over the course of the 9-week dose-titration period to a maximum dose of 03 mg BID Although doses could be reduced based on tolerability the final dosage reached was required to be stable during the 13-week treatment period prior to evaluation at Week 22
Subjects could receive concomitant oral disease-specific PAH therapy consisting of an ERA andor an agent acting on the nitric oxide pathway a PDE-5 inhibitor or a sGC stimulator provided the dose had remained stable for at least 3 months prior to the start of screening It was recommended that subjects continue the same dose and regimen of these medications for the duration of the study With the exception of prostanoids the use of other supporting therapies which may affect PAH was also permitted
During the study assessments of efficacy were performed including PVR and other hemodynamic parameters as determined by RHC the 6MWT assessment of clinical worsening BNP and NT-proBNP levels WHONYHA functional class assessment of PAH Safety assessments included standard evaluations of AEs clinical laboratory values vital signs and ECG measurements
At the end of the maintenance period subjects who did not choose to participate in the OLE study were to discontinue study drug ralinepag or placebo All subjects that chose to continue in the OLE study were to remain on study drug until the follow-up visit at Week 25 This visit served as the baseline visit for the OLE study if the subject was eligible and chose to participate
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