Evaluation of the Safety of Relaxin in Preeclampsia

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00333307
First received: June 1, 2006
Last updated: March 12, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia


Condition Intervention Phase
Pre-Eclampsia
Drug: recombinant human relaxin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

Primary Outcome Measures:
  • maternal adverse experiences
  • fetal adverse experiences
  • neonatal adverse experiences

Secondary Outcome Measures:
  • preeclampsia assessments
  • vital signs
  • physical examinations
  • clinical laboratory assessments

Estimated Enrollment: 18
Study Start Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333307

Locations
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Investigators
Study Director: Sam Teichman, MD Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00333307     History of Changes
Other Study ID Numbers: RLX.PE.001
Study First Received: June 1, 2006
Last Updated: March 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:
relaxin
preeclampsia

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014