Evaluation of the Safety of Relaxin in Preeclampsia
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe...
Brief Summary
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”
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: recombinant human relaxin
Outcome Measures for this Clinical Trial
Primary Measures
- maternal adverse experiences
- fetal adverse experiences
- neonatal adverse experiences
Secondary Measures
- preeclampsia assessments
- vital signs
- physical examinations
- clinical laboratory assessments
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Corthera, Inc. Industry
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director Corthera, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00333307
Study ID Number: RLX.PE.001
ClinicalTrials.gov Identifier: NCT00333307
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00333307
