Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125918
Status:
COMPLETED
Last Update Posted:
2008-02-21
First Post:
2005-08-01
Brief Title:
PHIRST-1 Tadalafil in the Treatment of Pulmonary Arterial Hypertension
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
PHIRST-1 Randomized Double-Blind Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 PDE5 Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2008-02
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter study The key measure of effectiveness of the study drug will be determined using a 6-minute walk test Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study PHIRST-2 Study procedures for both studies PHIRST-1 and PHIRST-2 will include routine blood tests medical history physical exams questionnaire responses and exercise tests
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H6D-MC-LVGY | None | None | None |