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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001617-14 | EudraCT Number |
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Novartis terminated this study due to internal, strategic decisions.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLX030 | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo to RLX030 as intravenous infusion for 72 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring. | Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks) |
| Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) | Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose. | 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) |
| Change From Baseline in Mean Maternal Arterial Pressure (Part 1) | Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose. | 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) |
| Change From Baseline on Maternal Proteinuria (Part 1) | Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR) | 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) |
| Decrease in Utero-placental Blood Flow (Part 1) | Blood flow to the fetus was monitored using via a Doppler. | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Days Before Delivery | From randomization until delivery (maximum of 3 weeks) |
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Key Inclusion criteria:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mobile | Alabama | 36604 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Between age 18 to 40 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study | Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed. | Posted | Number | Participants | Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks) |
|
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The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RLX030- Maternal | Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| RLX030 |
| Drug |
RLX030 1 mg/mL vials |
|
| Change in Fetal Heart Rate (Part 1) |
Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph. |
| During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) |
| Improvement in Renal Function Assessed by Increase in Creatinine Clearance | From randomization until 4-6 weeks post partum (maximum 8 weeks) |
| Rate of Spontaneous Delivery and/or Mode of Delivery | From randomization to delivery (maximum of 3 weeks) |
| Number of Patients With Absence of Anti-serelaxin Antibodies | From Randomization until 4-6 weeks post partum (maximum of 8 weeks) |
| 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 ) |
| Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile | Randomization to delivery (maximum of 3 weeks) |
| Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
| Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
| Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
| Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
| Pharmacokinetics of RLX030: Mean Residence Time (MRT) | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
| Lexington |
| Kentucky |
| 40503 |
| United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Galveston | Texas | 77555-0587 | United States |
| Novartis Investigative Site | Modena | MO | 41100 | Italy |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
| OG002 | RLX030- Neonates Born to Patients | Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received |
| OG003 | Placebo- Neonates Born to Patients | Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia |
|
|
| Primary | Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1) | Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | 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) |
|
|
| Primary | Change From Baseline in Mean Maternal Arterial Pressure (Part 1) | Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | 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) |
|
|
| Primary | Change From Baseline on Maternal Proteinuria (Part 1) | Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | 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) |
|
|
| Primary | Decrease in Utero-placental Blood Flow (Part 1) | Blood flow to the fetus was monitored using via a Doppler. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) |
|
|
| Primary | Change in Fetal Heart Rate (Part 1) | Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks) |
|
|
| Primary | Improvement in Renal Function Assessed by Increase in Creatinine Clearance | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | From randomization until 4-6 weeks post partum (maximum 8 weeks) |
|
|
| Primary | Rate of Spontaneous Delivery and/or Mode of Delivery | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | From randomization to delivery (maximum of 3 weeks) |
|
|
| Primary | Number of Patients With Absence of Anti-serelaxin Antibodies | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | 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) | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | up to 4 - 6 weeks post partum (maximum of 8 weeks ) |
|
|
| Primary | Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Randomization to delivery (maximum of 3 weeks) |
|
|
| Primary | Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
|
|
| 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 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
|
|
| Primary | Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
|
|
| Primary | Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
|
|
| Primary | Pharmacokinetics of RLX030: Mean Residence Time (MRT) | Blood concentrations of RLX-030 was assayed to determine this PK parameter. | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 |
|
|
| Secondary | Mean Number of Days Before Delivery | No formal analysis was performed as the study was terminated after three patients were enrolled and dosed | Posted | From randomization until delivery (maximum of 3 weeks) |
|
|
| 2 |
| 2 |
| 2 |
| 2 |
| EG001 | RLX030- Neonates Born to Patients | Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received | 2 | 2 | 2 | 2 |
| EG002 | Placebo- Maternal | Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia | 1 | 1 | 1 | 1 |
| EG003 | Placebo- Neonates Born to Patients | Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia | 1 | 1 | 0 | 1 |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Mechanical ventilation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.