Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 3:33 PM
Study NCT ID:
NCT02353806
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamie.morgan@utsouthwestern.edu', 'phone': '214-645-3838', 'title': 'Jamie Morgan, MD', 'phoneExt': '2147665011', 'organization': 'University of Texas Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve for Amlodipine in the Maternal Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '19.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.', 'unitOfMeasure': '(hr*ng)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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'}, {'type': 'PRIMARY', 'title': 'Time to Maximal Concentration in the Maternal Serum.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Maximal Amlodipine Maternal Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Half-life of Amlodipine in Maternal Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The half-life of amlodipine in the maternal plasma in the peripartum period was measured.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clearance Rate of Plasma Amlodipine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': '109.7', 'spread': '58.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The clearance rate of amlodipine from the maternal plasma was measured.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'title': 'Infant cord blood plasma amlodipine concentration', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.29', 'groupId': 'OG000'}]}]}, {'title': 'Maternal serum amlodipine concentration', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery', 'description': 'Maternal and cord blood amlodipine levels/concentrations will be determined.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Amlodipine Concentration in Breastmilk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Amlodipine concentrations in maternal breast milk were undetectable at the lower limit of assay detection (\\<0.1 ng/mL).', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The concentration of amlodipine besylate was measured in breastmilk samples.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Amlodipine concentrations in infant plasma were undetectable at the lower limit of assay detection (\\<0.1 ng/mL)', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Infant blood sample drawn at approximately 36 hours of life', 'description': 'Infant amlodipine level/concentration will be determined.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 16 patients enrolled in the study, only 8 continued in the study and allowed their infant's to have study sampling performed."}, {'type': 'SECONDARY', 'title': 'Neonatal Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Infant's Born to Women Taking Amlodipine Besylate", 'description': "Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."}], 'classes': [{'categories': [{'measurements': [{'value': '3281', 'spread': '525', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Neonatal weight at the time of birth.', 'description': 'The neonatal weight at birth was collected.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infant Gestational Age at Delivery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Infant's Born to Women Taking Amlodipine Besylate", 'description': "Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies."}], 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Gestational age at the time of birth', 'description': 'The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infant Length of Stay.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Infant's Born to Women Taking Amlodipine Besylate", 'description': "Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time from birth to hospital discharge', 'description': 'The length of stay of infants born to women taking amlodipine besylate will be collected.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Infant Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Infant's Born to Women Taking Amlodipine Besylate", 'description': "Infant's born to women already taking amlodipine besylate 5 mg for the treatment of chronic hypertension in pregnancy and who planned to breastfeed their babies.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician."}], 'classes': [{'title': 'Admission to the NICU', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major neonatal complications (IVH, apnea, seizure)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During neonatal hospitalization', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregnant Women Taking Amlodipine', 'description': '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.\n\nAmlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'This study only included pregnant women.', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2015-01-26', 'resultsFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-15', 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve for Amlodipine in the Maternal Serum', 'timeFrame': 'Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.'}, {'measure': 'Time to Maximal Concentration in the Maternal Serum.', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.'}, {'measure': 'Maximal Amlodipine Maternal Serum Concentration', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.'}, {'measure': 'Half-life of Amlodipine in Maternal Plasma', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The half-life of amlodipine in the maternal plasma in the peripartum period was measured.'}, {'measure': 'Clearance Rate of Plasma Amlodipine', 'timeFrame': 'Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The clearance rate of amlodipine from the maternal plasma was measured.'}, {'measure': 'Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)', 'timeFrame': 'Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery', 'description': 'Maternal and cord blood amlodipine levels/concentrations will be determined.'}, {'measure': 'Amlodipine Concentration in Breastmilk', 'timeFrame': 'Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing', 'description': 'The concentration of amlodipine besylate was measured in breastmilk samples.'}, {'measure': 'Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)', 'timeFrame': 'Infant blood sample drawn at approximately 36 hours of life', 'description': 'Infant amlodipine level/concentration will be determined.'}], 'secondaryOutcomes': [{'measure': 'Neonatal Birth Weight', 'timeFrame': 'Neonatal weight at the time of birth.', 'description': 'The neonatal weight at birth was collected.'}, {'measure': 'Infant Gestational Age at Delivery.', 'timeFrame': 'Gestational age at the time of birth', 'description': 'The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.'}, {'measure': 'Infant Length of Stay.', 'timeFrame': 'Time from birth to hospital discharge', 'description': 'The length of stay of infants born to women taking amlodipine besylate will be collected.'}, {'measure': 'Major Infant Complications', 'timeFrame': 'During neonatal hospitalization', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amlodipine besylate', 'Breast milk', 'Pharmacokinetics', 'Chronic hypertension', 'Pregnancy'], 'conditions': ['Chronic Hypertension in Pregnancy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older;\n* Pregnant female\n* Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;\n* Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery\n* Breastfeeding or breast and bottle-feeding their infant\n\nExclusion Criteria:\n\n* Known kidney disease\n* Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage\n* Administration of greater than 5 mg of amlodipine in 24 hour period'}, 'identificationModule': {'nctId': 'NCT02353806', 'briefTitle': 'Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation', 'orgStudyIdInfo': {'id': '042014-059'}, 'secondaryIdInfos': [{'id': 'UL1TR001105', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001105', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnant women taking amlodipine', 'description': '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.', 'interventionNames': ['Drug: Amlodipine besylate']}], 'interventions': [{'name': 'Amlodipine besylate', 'type': 'DRUG', 'description': 'Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.', 'armGroupLabels': ['Pregnant women taking amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health and Hospital System', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Jamie L Morgan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal Fetal Medicine Fellow', 'investigatorFullName': 'Jamie Morgan', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}