Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333307
Status:
SUSPENDED
Last Update Posted:
2010-03-16
First Post:
2006-06-01
Brief Title:
Evaluation of the Safety of Relaxin in Preeclampsia
Sponsor:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Organization:
Corthera Incformerly BAS Medical Inc a member of the Novartis group of companies
Study Overview
Official Title:
A Phase I Randomized Double-Blind Placebo-Controlled Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin rhRlx in Subjects With Preeclampsia
Status:
SUSPENDED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia
Detailed Description:
The effects of relaxin may be beneficial in the treatment of women with preeclampsia This study will preliminarily evaluate the maternal fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia
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