A study to assess how safe and efficient RLX030 is in pre-eclampsia

• Conditions: Pre-eclampsia; MedDRA version: 14.1Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-001617-14-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-10
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

- Women that are 28- 33 weeks (+4 days) pregnant with a diagnosis of pre- eclampsia or superimposed pre-eclampsia requiring hospitalization - Fetus deemed in reasonably good health Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Severe hypertension and /or those receiving anti-hypertensive treatment at time of enrollment - Severe headaches, visual changes, or altered mentation - Upper abdominal pain, nausea, or vomiting - Low blood platelet count - Diagnosis of a seizure disorder that requires chronic medication - Those receiving active anti-coagulation therapy - Pre-gestational diabetes (Type 1 or Type 2) - Allergy to magnesium sulfate or steroids - Known major fetal anomaly - Multifetal gestation Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified