Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 3:09 AM
Study NCT ID:
NCT00800592
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2008-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil IV Bolus Study
Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Organization:
Study Overview
Official Title:
An Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH).
Status:
COMPLETED
Status Verified Date:
2021-01
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 objective of this study is to assess the safety, tolerability and pharmacokinetics of intravenous sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension already receiving and stable on oral Revatio 20 mg TID.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: