This trial is active, not recruiting.

Condition chronic hypertension in pregnancy
Treatment amlodipine besylate
Phase phase 4
Sponsor University of Texas Southwestern Medical Center
Collaborator National Center for Advancing Translational Science (NCATS)
Start date January 2015
End date July 2016
Trial size 16 participants
Trial identifier NCT02353806, 042014-059, UL1TR001105


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Composite of PK parameters in blood and breast milk (elimination half-life, time to peak serum concentration, maximal concentration, volume of distribution and area under the curve)
time frame: Paired blood and breast milk samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing
Drug levels/concentration in cord blood (amlodipine levels/concentrations)
time frame: Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery
Drug level/concentration in infant blood (amlodipine level/concentration)
time frame: Infant blood sample drawn at approximately 36 hours of life

Secondary Outcomes

Neonatal clinical status (A range of clinical information will be collected including infant weight, Apgar scores, hemodynamic parameters such as blood pressure and heart rate as well as physical examination findings and hospital course)
time frame: Neonates will be followed for the duration of the delivery hospitalization, an expected average of 3 days

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - 18 years or older; - Pregnant female - Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy; - Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery - Breastfeeding or breast and bottle-feeding their infant Exclusion Criteria: - Known kidney disease - Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage - Administration of greater than 5 mg of amlodipine in 24 hour period

Additional Information

Official title Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Principal investigator Jamie L Morgan, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center.