Evaluation of the Safety of Relaxin in Preeclampsia - Tabular View

Tracking Information

First Received Date ^ICMJE

June 1, 2006

Last Updated Date

April 7, 2008

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333307 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

preeclampsia assessments
vital signs
physical examinations
clinical laboratory assessments

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Safety of Relaxin in Preeclampsia

Official Title ^ICMJE

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Pre-Eclampsia

Intervention ^ICMJE

Drug: recombinant human relaxin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sam Teichman, MD

(925) 314-0569

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00333307

Responsible Party

Study ID Numbers ^ICMJE

RLX.PE.001

Study Sponsor ^ICMJE

Corthera, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sam Teichman, MD

Corthera, Inc.

Information Provided By

Corthera, Inc.

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP