Trial · NCT01566630
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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 ) | |
| Primary | Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile | 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 | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. |
| 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 | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. |
| Primary | Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1 | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. |
| Primary | Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1 | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. |
| Primary | Pharmacokinetics of RLX030: Mean Residence Time (MRT) | Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 | Blood concentrations of RLX-030 was assayed to determine this PK parameter. |
| Secondary | Mean Number of Days Before Delivery | From randomization until delivery (maximum of 3 weeks) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01566630/registered