Evaluation of the Safety of Relaxin in Preeclampsia

Pre-Eclampsia Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00333307
• Other study ID #: RLX.PE.001
• Status: Suspended
• Phase: Phase 1
• First received: June 1, 2006
• Last updated: March 12, 2010
• Start date: October 2006

Study information

• Verified date: March 2010
• Source: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Eclampsia

Intervention

Drug:
• recombinant human relaxin

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Central Baptist Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal adverse experiences
Primary	fetal adverse experiences
Primary	neonatal adverse experiences
Secondary	preeclampsia assessments
Secondary	vital signs
Secondary	physical examinations
Secondary	clinical laboratory assessments