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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01566630
First received: March 27, 2012
Last updated: August 26, 2014
Last verified: August 2014

March 27, 2012
August 26, 2014
May 2013
August 2014   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 part 1 ] [ Designated as safety issue: Yes ]
    Blood flow to the fetus will be monitored using via a Doppler.
  • Change in fetal heart rate (Part 1) [ Time Frame: during treatment period of a maximum 72 hours infusion prior to delivery and during delivery in part 1 ] [ Designated as safety issue: Yes ]
    Heart rate of fetus will be monitored continuously throughout 72 hour treatment period using a cardiotocographer.
  • Pharmacokinetics of RLX030: area under the blood concentration-time curve from time zero to infinity (AUCinf)-Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    blood concentrations of RLX-030 will be assayed to determine AUCinf (if appropriate)
  • Pharmacokinetics of RLX030: area under the blood concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)-Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be assayed to determine AUClast (if appropriate)
  • Pharmacokinetics of RLX030: blood concentration at 24 hour (C 0-24h) after administration- Part 1 [ Time Frame: 24 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    blood concentrations of RLX-030 will be assayed to determine C 0-24h (if appropriate).
  • Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)- Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be obtained.
  • Pharmacokinetics of RLX030: mean residence time (MRT) [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be assayed to determine MRT (if appropriate)
Same as current
Complete list of historical versions of study NCT01566630 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pre-eclampsia
  • Drug: Placebo
    Placebo to RLX030 as intravenous infusion for 72 hours
  • Drug: RLX030
    RLX030 1 mg/mL vials
  • Experimental: RLX030

    In part 1, within each cohort, two (2) patients per cohort will be treated open label with RLX030 and two (2) patients will be treated double blind with RLX030 as intravenous infusion for 72 hours. There will be 3 cohorts in part 1 with different doses of RLX030.

    In part 2, there is no open label treatment on RLX030. In part 2, patients will be randomized in a double-blind fashion to this arm with the optimal dose of RLX030 as intravenous infusion for 72 hours as determined from part 1.

    Intervention: Drug: RLX030
  • Placebo Comparator: Placebo

    In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts.

    In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
August 2014
August 2014   (final data collection date for primary outcome measure)

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

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 inclusion/exclusion criteria may apply

Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT01566630
CRLX030A2205, 2011-001617-14
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP