Clinical Trial: Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome:
- Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study [ Time Frame: Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks) ]Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.
- Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks) ]Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.
- Change From Baseline in Mean Maternal Arterial Pressure (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks) ]Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.
- Change From Baseline on Maternal Proteinuria (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks) ]Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)
- Decrease in Utero-placental Blood Flow (Part 1) [ Time Frame: During treatment period of
Original Primary Outcome:
- Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study [ Time Frame: Prior to delivery until 4-6weeks post partum ]Safety and tolerability will be assessed by adverse events/serious adverse event and death monitoring.
- Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ]Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.
- Change From Baseline in Mean Maternal Arterial Pressure (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ]Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.
- Change From Baseline on Maternal Proteinuria (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ]Pre-eclampsia will also be monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)
- Decrease in Utero-placental Blood Flow (Part 1) [ Time Frame: During treatment period of a maximum 72 hours infusion prior to delivery and during delivery in par
Current Secondary Outcome: Mean Number of Days Before Delivery [ Time Frame: From randomization until delivery (maximum of 3 weeks) ]
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: March 27, 2012
Date Started: May 2013
Date Completion:
Last Updated: October 12, 2015
Last Verified: October 2015
- Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study [ Time Frame: Prior to delivery until 4-6weeks post partum ]
