Back to resultsEvaluation of the Safety of Relaxin in Preeclampsia
Primary Purpose
Pre-Eclampsia
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant human relaxin
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Eclampsia focused on measuring relaxin, preeclampsia
Eligibility Criteria
Inclusion Criteria: Diagnosis of preeclampsia Hospital admission for expectant management Exclusion Criteria: Eclampsia or history of seizures Vaginal bleeding Multifetal gestation Requirement for immediate delivery
Sites / Locations
- Central Baptist Hospital
- University of Cincinnati
Outcomes
Primary Outcome Measures
maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences
Secondary Outcome Measures
preeclampsia assessments
vital signs
physical examinations
clinical laboratory assessments
Full Information
NCT ID
NCT00333307
First Posted
June 1, 2006
Last Updated
March 12, 2010
Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
1. Study Identification
Unique Protocol Identification Number
NCT00333307
Brief Title
Evaluation of the Safety of Relaxin in Preeclampsia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Suspended
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
Keywords
relaxin, preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
recombinant human relaxin
Primary Outcome Measure Information:
Title
maternal adverse experiences
Title
fetal adverse experiences
Title
neonatal adverse experiences
Secondary Outcome Measure Information:
Title
preeclampsia assessments
Title
vital signs
Title
physical examinations
Title
clinical laboratory assessments
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of preeclampsia
Hospital admission for expectant management
Exclusion Criteria:
Eclampsia or history of seizures
Vaginal bleeding
Multifetal gestation
Requirement for immediate delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Teichman, MD
Organizational Affiliation
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Official's Role
Study Director
Facility Information:
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety of Relaxin in Preeclampsia
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