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

This study has been terminated.
(Novartis terminated this study due to internal, strategic decisions.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01566630
First received: March 27, 2012
Last updated: October 12, 2015
Last verified: October 2015
Results First Received: August 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pre-eclampsia
Interventions: Drug: Placebo
Drug: RLX030

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RLX030 Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
Placebo Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.

Participant Flow:   Overall Study
    RLX030     Placebo  
STARTED     2     1  
COMPLETED     2     1  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
RLX030 Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
Placebo Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
Total Total of all reporting groups

Baseline Measures
    RLX030     Placebo     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age, Customized [1]
[units: Participants]
     
Between age 18 to 40 years     2     1     3  
Gender  
[units: Participants]
     
Female     2     1     3  
Male     0     0     0  
[1] Between age 18 to 40



  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Primary:   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) ]

5.  Primary:   Decrease in Utero-placental Blood Flow (Part 1)   [ Time Frame: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) ]

6.  Primary:   Change in Fetal Heart Rate (Part 1)   [ Time Frame: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) ]

7.  Primary:   Improvement in Renal Function Assessed by Increase in Creatinine Clearance   [ Time Frame: From randomization until 4-6 weeks post partum (maximum 8 weeks) ]

8.  Primary:   Rate of Spontaneous Delivery and/or Mode of Delivery   [ Time Frame: From randomization to delivery (maximum of 3 weeks) ]

9.  Primary:   Number of Patients With Absence of Anti-serelaxin Antibodies   [ Time Frame: From Randomization until 4-6 weeks post partum (maximum of 8 weeks) ]

10.  Primary:   Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)   [ Time Frame: up to 4 - 6 weeks post partum (maximum of 8 weeks ) ]

11.  Primary:   Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile   [ Time Frame: Randomization to delivery (maximum of 3 weeks) ]

12.  Primary:   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 ]

13.  Primary:   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 ]

14.  Primary:   Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1   [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ]

15.  Primary:   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 ]

16.  Primary:   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 ]

17.  Secondary:   Mean Number of Days Before Delivery   [ Time Frame: From randomization until delivery (maximum of 3 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01566630     History of Changes
Other Study ID Numbers: CRLX030A2205
2011-001617-14 ( EudraCT Number )
Study First Received: March 27, 2012
Results First Received: August 6, 2015
Last Updated: October 12, 2015
Health Authority: United States: Food and Drug Administration
Germany: Ministry of Health
Italy: Ministry of Health