Evaluation of the Safety of Relaxin in Preeclampsia

NCT ID: NCT00333307

Last Updated: 2010-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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

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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.

Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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recombinant human relaxin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sam Teichman, MD

Role: STUDY_DIRECTOR

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

Locations

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Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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RLX.PE.001

Identifier Type: -

Identifier Source: org_study_id

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