Evaluation of the Safety of Relaxin in Preeclampsia | NCT00333307

Studies
Evaluation of the Safety of Relaxin in Preeclampsia

NCT00333307

Sponsor

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

Status

Suspended

Last Update Posted

Mar 16, 2010Estimated

Enrollment

18Estimated

Phase

Phase 1

Conditions

Pre-Eclampsia

Interventions

recombinant human relaxin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2010

Last Update Posted Date

Mar 16, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Name	Type	Description	Arm Group Labels	Other Names
recombinant human relaxin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences

Secondary Outcomes

Measure	Description	Time Frame
preeclampsia assessments
vital signs
physical examinations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam Teichman, MD	Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Baptist Hospital		Lexington	Kentucky	40503	United States
University of Cincinnati

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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Not provided

Browse Branches

Not provided