Trials / Terminated
TerminatedNCT01566630
Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
An Adaptive Multicentre, Randomized, Partially Double-blind, Placebo-controlled Study to Assess the Safety, PK and PD/Efficacy of RLX030 in Women With Pre-eclampsia
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo to RLX030 as intravenous infusion for 72 hours |
| DRUG | RLX030 | RLX030 1 mg/mL vials |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2012-03-29
- Last updated
- 2015-11-05
- Results posted
- 2015-11-05
Locations
5 sites across 2 countries: United States, Italy
Source: ClinicalTrials.gov record NCT01566630. Inclusion in this directory is not an endorsement.