Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494533
Status:
TERMINATED
Last Update Posted:
2014-01-29
First Post:
2007-06-27
Brief Title:
Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
Treprostinil for Untreated Symptomatic PAH Trial A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety issues related to outpatient intravenous infusion in India
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUST-1
Brief Summary:
Multi-center double-blind placebo-controlled randomized parallel study comparing continuous intravenous IV Remodulin to placebo in patients with pulmonary arterial hypertension either primary PPH or associated with human immunodeficiency virus HIV infection or collagen vascular disease
Detailed Description:
None
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