Ignite Creation Date:
2024-05-06 @ 8:53 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02847260
Status:
COMPLETED
Last Update Posted:
2017-10-17
First Post:
2016-07-25
Brief Title:
Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin Therapy in PAH Subjects RAPID
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A 16 Week Open Label Multi-centre Study to Evaluate the Safety Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2017-09
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:
RAPID
Brief Summary:
The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration regimen of subcutaneous Remodulin therapy in patients with PAH
Detailed Description:
This is an open label single territory multi-centre study in subjects with pulmonary arterial
hypertension PAH Subjects were treatment naïve or receiving an approved endothelin receptor antagonist ERA and or phosphodiesterase PDE-5 inhibitor for at least 60 days prior to screening and maintained on a stable dose for at least 30 days
hypertension PAH Subjects were treatment naïve or receiving an approved endothelin receptor antagonist ERA and or phosphodiesterase PDE-5 inhibitor for at least 60 days prior to screening and maintained on a stable dose for at least 30 days
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