The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe...
Date First Received: June 1, 2006
Last Updated: April 7, 2008
Verified by: BAS Medical, April 2008
Clinical Trial Phase: Phase 1 | Start Date: October 2006
Overall Status: Recruiting
Estimated Enrollment: 18
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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.
Outcome Measures for this Clinical Trial
Primary:
- maternal adverse experiences
- fetal adverse experiences
- neonatal adverse experiences
Secondary:
- 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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: BAS Medical
Central Baptist Hospital
Lexington Kentucky 40503 United States
University of Cincinnati
Cincinnati Ohio 45267 United States
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director BAS Medical
Overall Contact: Sam Teichman, MD (925) 314-0569
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
