NCT00333307

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

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

First QC Date

June 1, 2006

Last Update Submit

March 12, 2010

Conditions

Pre-Eclampsia

Keywords

relaxinpreeclampsia

Outcome Measures

Primary Outcomes (3)

  • maternal adverse experiences

  • fetal adverse experiences

  • neonatal adverse experiences

Secondary Outcomes (4)

  • preeclampsia assessments

  • vital signs

  • physical examinations

  • clinical laboratory assessments

Interventions

recombinant human relaxinDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of preeclampsia
  • Hospital admission for expectant management

You may not qualify if:

  • Eclampsia or history of seizures
  • Vaginal bleeding
  • Multifetal gestation
  • Requirement for immediate delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sam Teichman, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2006

First Posted

June 5, 2006

Study Start

October 1, 2006

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

US(2)