A Phase 2 interventional study of Serelaxin and Placebo in Labor, Induced, sponsored by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies. Completed at 3 sites in Russian Federation. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-05-07.
Sponsored by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A.
Drug: Serelaxin
Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A.
Drug: Serelaxin
Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B.
Drug: Serelaxin
Participants who received IV infusion of placebo, some during part A and others during part B.
Drug: Placebo
Cervical ripening
Time frame: Through 24 hours
Progression to active labor and delivery
Time frame: Within 7 Days of Drug Infusion
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies