Trial · NCT01566630
Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
NCT01566630, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2015-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia. Trials, record NCT01566630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01566630
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
- NCT number
- NCT01566630
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Pre-eclampsia
- Interventions
- Placebo, RLX030
- First posted
- 2012-03-29
- Last updated
- 2015-11-05
- Other registries' IDs
- eudract:2011-001617-14
- Results first posted
- 2015-11-05
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | 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. |
| Primary | Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) | 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. |
| Primary | Change From Baseline in Mean Maternal Arterial Pressure (Part 1) | 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. |
| Primary | Change From Baseline on Maternal Proteinuria (Part 1) | 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) |
| Primary | Decrease in Utero-placental Blood Flow (Part 1) | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) | Blood flow to the fetus was monitored using via a Doppler. |
| Primary | Change in Fetal Heart Rate (Part 1) | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) | Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph. |
| Primary | Improvement in Renal Function Assessed by Increase in Creatinine Clearance | From randomization until 4-6 weeks post partum (maximum 8 weeks) | |
| Primary | Rate of Spontaneous Delivery and/or Mode of Delivery | From randomization to delivery (maximum of 3 weeks) | |
| Primary | Number of Patients With Absence of Anti-serelaxin Antibodies | From Randomization until 4-6 weeks post partum (maximum of 8 weeks) | |
| 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) | up to 4 - 6 weeks post partum (maximum of 8 weeks ) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed. | Participants | NUMBER |
| PRIMARY | Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) | 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) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Change From Baseline in Mean Maternal Arterial Pressure (Part 1) | 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) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Change From Baseline on Maternal Proteinuria (Part 1) | 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) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Decrease in Utero-placental Blood Flow (Part 1) | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Change in Fetal Heart Rate (Part 1) | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Improvement in Renal Function Assessed by Increase in Creatinine Clearance | From randomization until 4-6 weeks post partum (maximum 8 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Rate of Spontaneous Delivery and/or Mode of Delivery | From randomization to delivery (maximum of 3 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| PRIMARY | Number of Patients With Absence of Anti-serelaxin Antibodies | From Randomization until 4-6 weeks post partum (maximum of 8 weeks) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | ||
| 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) | up to 4 - 6 weeks post partum (maximum of 8 weeks ) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | RLX030 - Maternal | Serious Adverse events | 2 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Placebo - Maternal | Serious Adverse events | 1 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | RLX030- Neonates Born to Patients | Serious Adverse events | 2 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Placebo- Neonates Born to Patients | Serious Adverse events | 1 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | RLX030 - Maternal | Death | 0 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Placebo - Maternal | Death | 0 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | RLX030- Neonates Born to Patients | Death | 0 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Placebo- Neonates Born to Patients | Death | 0 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | RLX030 - Maternal | Non-serious AEs | 2 | Participants | |
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Placebo - Maternal | Non-serious AEs | 1 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RLX030 | 2 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | RLX030 | 2 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | RLX030 | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | RLX030- Maternal | 0 | 2 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | RLX030- Neonates Born to Patients | 1 | 2 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo- Maternal | 0 | 1 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo- Neonates Born to Patients | 0 | 1 | |
| other | Constipation | Gastrointestinal disorders | RLX030- Maternal | 0 | 2 | |
| other | Constipation | Gastrointestinal disorders | RLX030- Neonates Born to Patients | 0 | 2 | |
| other | Constipation | Gastrointestinal disorders | Placebo- Maternal | 1 | 1 | |
| other | Constipation | Gastrointestinal disorders | Placebo- Neonates Born to Patients | 0 | 1 | |
| other | Nausea | Gastrointestinal disorders | RLX030- Maternal | 0 | 2 | |
| other | Nausea | Gastrointestinal disorders | RLX030- Neonates Born to Patients | 0 | 2 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RLX030- Maternal | ||
| Total, all-cause mortality | RLX030- Neonates Born to Patients | ||
| Total, all-cause mortality | Placebo- Maternal | ||
| Total, all-cause mortality | Placebo- Neonates Born to Patients | ||
| Total, other adverse events | RLX030- Maternal | 2 | 2 |
| Total, other adverse events | RLX030- Neonates Born to Patients | 2 | 2 |
| Total, other adverse events | Placebo- Maternal | 1 | 1 |
| Total, other adverse events | Placebo- Neonates Born to Patients | 0 | 1 |
| Total, serious adverse events | RLX030- Maternal | 2 | 2 |
| Total, serious adverse events | RLX030- Neonates Born to Patients | 2 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01566630
GET https://conductscience.org/api/trials/v1/NCT01566630/events?page=2