Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03449524
Status:
TERMINATED
Last Update Posted:
2020-08-10
First Post:
2018-02-14
Brief Title:
PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension PAH
Sponsor:
Complexa Inc
Organization:
Complexa Inc
Study Overview
Official Title:
Phase 2 Multicenter Double-Blind Placebo Controlled Efficacy Safety and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
LOE
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAH
Brief Summary:
This is a multicenter double-blind placebo-controlled study to evaluate the safety efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH
Detailed Description:
This is a multicenter double-blind placebo-controlled study to evaluate the safety efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH
The study will be performed in approximately 50 study centers across the United States of America and Europe The recruitment period is anticipated to be approximately 24 months Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study
Study participation for each subject will last approximately 8 months The study will consist of a screening period within 30 days prior to dosing 180 days approximately 6 months treatment period and approximately 14 days follow-up period after the end of treatment visit
The study will be performed in approximately 50 study centers across the United States of America and Europe The recruitment period is anticipated to be approximately 24 months Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study
Study participation for each subject will last approximately 8 months The study will consist of a screening period within 30 days prior to dosing 180 days approximately 6 months treatment period and approximately 14 days follow-up period after the end of treatment visit
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