drugset / Trial / NCT01566630

Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia

NCT01566630 ↗

Phase 2 Terminated 3 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed in two parts. Part 1 will assess the safety and tolerability of different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can prolong pregnancy in women with pre-eclampsia.

Timeline

Start
2013-05
Primary completion
2014-08
Completion
2014-08

Outcome

Outcome not reported

Stopped (Business): “Novartis terminated this study due to internal, strategic decisions.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Serelaxin Protein / enzyme biologic 1 mg/ml Intravenous

Indications