Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02279745
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2014-10-25
Brief Title:
Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Open-label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-11
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 open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization WHO Group 1 pulmonary arterial hypertension PAH who have completed Study APD811-003 or who were assigned to receive placebo and were discontinued due to clinical worsening
Detailed Description:
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with WHO Group 1 PAH who completed Study APD811-003 Subjects who completed Study APD811-003 and met eligibility criteria for Study APD811-007 were enrolled Additionally placebo-treated subjects who discontinued study drug treatment due to clinical worsening in Study APD811-003 were permitted to enroll in Study APD811-007 upon approval of the medical monitor provided that all end of study procedures including right heart catheterization RHC were performed per the study protocol The Week 25 Visit in Study APD811-003 served as the Baseline Visit for Study APD811-007
All subjects enrolled in Study APD811-007 received open-label treatment with ralinepag The starting dose and titration schedule were individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003 Adjustments in the dose and titration schedule were made according to subject tolerability
After an individual subject completed Study APD811-003 and that subjects database was locked subject unblinding occurred Subjects on active treatment ralinepag remained on their current dose and had onsite clinical assessments performed every 3 months until the subject was discontinued from the study
Subjects in the placebo treatment group underwent a dose titration period until a stable maximum tolerated dose MTD was reached up to 9 weeks followed by a treatment period after the MTD was determined during which monthly onsite clinic assessments were performed for the first 3 months and then every 3 months until the subject was discontinued from the study or the study was terminated Dose reductions could be made at any time for safety reasons Incremental dose increases were also allowed during the Treatment Period at the discretion of the Investigator as clinically indicated and according to the stepwise titration scheme
Subjects were assessed for clinical worsening during each clinic visit If clinical worsening was confirmed the Investigator could have opted to either continue treatment with ralinepag at the current dose increase the dose of ralinepag interrupt treatment or discontinue the subject at hisher discretion
In addition attempts were made to contact all subjects at the time of Study APD811-007 termination to assess their vital mortality status After the last subject enrolled in Study APD811-007 completed approximately 6 months of the study a cumulative all-subject data analysis was performed for all subjects who entered the study Subjects continued to have visits to the clinic every 3 months until the Sponsor discontinued the study At the time of the Sponsors decision to discontinue the study all ongoing subjects completed an End of Study Visit A 28-day Follow-up Visit was conducted to ensure appropriate subject safety Subjects who remained on ralinepag were eligible to transition into the Phase 3 open-label extension study ROR-PH-303 prior to APD811-007 study termination For those subjects that did not enroll in Study ROR-PH-303 a 28-day Follow-up Visit was conducted to evaluate ongoing subject safety including survival status
All subjects enrolled in Study APD811-007 received open-label treatment with ralinepag The starting dose and titration schedule were individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003 Adjustments in the dose and titration schedule were made according to subject tolerability
After an individual subject completed Study APD811-003 and that subjects database was locked subject unblinding occurred Subjects on active treatment ralinepag remained on their current dose and had onsite clinical assessments performed every 3 months until the subject was discontinued from the study
Subjects in the placebo treatment group underwent a dose titration period until a stable maximum tolerated dose MTD was reached up to 9 weeks followed by a treatment period after the MTD was determined during which monthly onsite clinic assessments were performed for the first 3 months and then every 3 months until the subject was discontinued from the study or the study was terminated Dose reductions could be made at any time for safety reasons Incremental dose increases were also allowed during the Treatment Period at the discretion of the Investigator as clinically indicated and according to the stepwise titration scheme
Subjects were assessed for clinical worsening during each clinic visit If clinical worsening was confirmed the Investigator could have opted to either continue treatment with ralinepag at the current dose increase the dose of ralinepag interrupt treatment or discontinue the subject at hisher discretion
In addition attempts were made to contact all subjects at the time of Study APD811-007 termination to assess their vital mortality status After the last subject enrolled in Study APD811-007 completed approximately 6 months of the study a cumulative all-subject data analysis was performed for all subjects who entered the study Subjects continued to have visits to the clinic every 3 months until the Sponsor discontinued the study At the time of the Sponsors decision to discontinue the study all ongoing subjects completed an End of Study Visit A 28-day Follow-up Visit was conducted to ensure appropriate subject safety Subjects who remained on ralinepag were eligible to transition into the Phase 3 open-label extension study ROR-PH-303 prior to APD811-007 study termination For those subjects that did not enroll in Study ROR-PH-303 a 28-day Follow-up Visit was conducted to evaluate ongoing subject safety including survival status
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