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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This is a phase IV prospective trial to collect and analyze information about the maternal pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum lactation. The study will also evaluate amlodipine concentrations in the infants of breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.
We plan to evaluate the pharmacokinetics of amlodipine besylate at the time of delivery, to determine if transplacental passage of the drug occurs. We will also examine the drug kinetics in postpartum lactation to establish whether amlodipine is excreted into breast milk. The outcomes of interest are plasma concentration of amlodipine at delivery and the drug concentrations in blood and breast milk over a twenty-hour steady-state period following milk-supply establishment. Fifteen patients already taking 5 mg of amlodipine during pregnancy for the treatment of chronic hypertension will be recruited from the antepartum Obstetric Complications Clinic at Parkland Hospital. Only women who are breastfeeding will be eligible for the study. Patients who elect to participate in the study will continue their amlodipine 5 mg dosing through delivery and into the postpartum period. Maternal blood will be drawn within one hour of delivery and fetal cord blood collected at the time of delivery. Patients will then have blood drawn over a 24 hour period beginning on postpartum day 2 after delivery following administration of their once-daily amlodipine dose. At each blood draw, the patient will also use a breast pump to express breast milk for paired analysis. Both blood and breast milk amlodipine levels will be calculated for all samples. The levels will be used to determine the pharmacokinetics of amlodipine in the peri- and postpartum patient, including concentrations in plasma and breast milk.
In addition to collecting maternal data, a range of clinical information will be collected on each study patient's infant including weight, Apgar scores, hemodynamic parameters, physical examination and hospital course. This information will be used to screen for any potential complications associated with infant exposure to amlodipine. An infant blood sample will also be obtained in conjunction with the routine neonatal blood collection that occurs at 1-2 days of postnatal life and this will be analyzed to determine serum amlodipine concentration in breastfeeding infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women taking amlodipine | Experimental | Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine besylate | Drug | Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve for Amlodipine in the Maternal Serum | The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured. | Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Time to Maximal Concentration in the Maternal Serum. | The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured. | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Maximal Amlodipine Maternal Serum Concentration | The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured. | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Half-life of Amlodipine in Maternal Plasma | The half-life of amlodipine in the maternal plasma in the peripartum period was measured. | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Clearance Rate of Plasma Amlodipine | The clearance rate of amlodipine from the maternal plasma was measured. | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations) | Maternal and cord blood amlodipine levels/concentrations will be determined. | Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Birth Weight | The neonatal weight at birth was collected. | Neonatal weight at the time of birth. |
| Infant Gestational Age at Delivery. | The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie L Morgan, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health and Hospital System | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregnant Women Taking Amlodipine | Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregnant Women Taking Amlodipine | Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Area Under the Curve for Amlodipine in the Maternal Serum | The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured. | Although 16 women were enrolled in the study, only 11 of the 16 had blood drawn at the time of delivery. This was due to limitations of study personnel availability to attend the deliveries of all study patients | Posted | Mean | Standard Deviation | (hr*ng)/mL | Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
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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 | Pregnant Women Taking Amlodipine | Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm. Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Morgan, MD | University of Texas Southwestern Medical Center | 214-645-3838 | 2147665011 | jamie.morgan@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Amlodipine Concentration in Breastmilk | The concentration of amlodipine besylate was measured in breastmilk samples. | Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
| Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration) | Infant amlodipine level/concentration will be determined. | Infant blood sample drawn at approximately 36 hours of life |
| Gestational age at the time of birth |
| Infant Length of Stay. | The length of stay of infants born to women taking amlodipine besylate will be collected. | Time from birth to hospital discharge |
| Major Infant Complications | Any major complications experienced by infants born to women taking amlodipine besylate including NICU admission, intraventricular hemorrhage, neonatal seizures, need for respiratory support and apnea were collected. | During neonatal hospitalization |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
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| Primary | Time to Maximal Concentration in the Maternal Serum. | The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured. | Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel. | Posted | Mean | Standard Deviation | Hours | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
|
|
|
| Primary | Maximal Amlodipine Maternal Serum Concentration | The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured. | Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel. | Posted | Mean | Standard Deviation | ng/mL | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
|
|
|
| Primary | Half-life of Amlodipine in Maternal Plasma | The half-life of amlodipine in the maternal plasma in the peripartum period was measured. | Posted | Mean | Standard Deviation | Hours | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
|
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| Primary | Clearance Rate of Plasma Amlodipine | The clearance rate of amlodipine from the maternal plasma was measured. | Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel. | Posted | Mean | Standard Deviation | L/hr | Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
|
|
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| Primary | Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations) | Maternal and cord blood amlodipine levels/concentrations will be determined. | Posted | Mean | Standard Deviation | ng/mL | Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery |
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| Primary | Amlodipine Concentration in Breastmilk | The concentration of amlodipine besylate was measured in breastmilk samples. | Posted | Mean | Standard Deviation | ng/mL | Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing |
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| Primary | Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration) | Infant amlodipine level/concentration will be determined. | Of the 16 patients enrolled in the study, only 8 continued in the study and allowed their infant's to have study sampling performed. | Posted | Mean | Standard Deviation | ng/mL | Infant blood sample drawn at approximately 36 hours of life |
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| Secondary | Neonatal Birth Weight | The neonatal weight at birth was collected. | Posted | Mean | Standard Deviation | grams | Neonatal weight at the time of birth. |
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| Secondary | Infant Gestational Age at Delivery. | The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected. | Posted | Mean | Standard Deviation | weeks | Gestational age at the time of birth |
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| Secondary | Infant Length of Stay. | The length of stay of infants born to women taking amlodipine besylate will be collected. | Posted | Mean | Standard Deviation | Days | Time from birth to hospital discharge |
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| Secondary | Major Infant Complications | Any major complications experienced by infants born to women taking amlodipine besylate including NICU admission, intraventricular hemorrhage, neonatal seizures, need for respiratory support and apnea were collected. | Posted | Number | Participants | During neonatal hospitalization |
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| 0 |
| 16 |
| 0 |
| 16 |
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