Ignite Creation Date:
2024-05-06 @ 9:05 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02893995
Status:
WITHDRAWN
Last Update Posted:
2017-05-09
First Post:
2016-08-24
Brief Title:
Safety Tolerability Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin Dose Titration in Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A 16-Week Open-Label Multi-Center Parallel Randomized Controlled Study to Compare the Safety Tolerability Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter parallel randomized 11 Slow Dose Titration Group Rapid Dose Titration Group two-group study to evaluate the safety tolerability pharmacokinetics and efficacy of slow and rapid dose titration regimens of subcutaneous Remodulin infusion in subjects with pulmonary arterial hypertension PAH The study will include about 50 subjects at up to 10 clinical trial centers in China The treatment phase of the study will last approximately 16 weeks Subjects who complete all required assessments will also be eligible to enter a long-term open-label extension study CVT-CV-004
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None