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

• Conditions: Pre-eclampsia; MedDRA version: 16.0Level: LLTClassification code 10027620Term: Mild or unspecified pre-eclampsiaSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001617-14-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-18
• Last Update Posted: 24 August 2015

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:
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