Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02882126
Status:
WITHDRAWN
Last Update Posted:
2017-05-09
First Post:
2016-08-24
Brief Title:
An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin in Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003
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WITHDRAWN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 a multicenter open-label trial to evaluate the safety of continued therapy with subcutaneous Remodulin in subjects with pulmonary arterial hypertension PAH who complete the CVT-CV-003 study The study will include about 50 subjects at up to 10 clinical trial centers in China who completed all required assessments in the CVT-CV-003 study Study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor
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