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Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

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ClinicalTrials.gov Identifier: NCT02353806
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Jamie Morgan, University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hypertension in Pregnancy Drug: Amlodipine besylate Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Amlodipine besylate
Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.




Primary Outcome Measures :
  1. Area Under the Curve for Amlodipine in the Maternal Serum [ Time Frame: Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.

  2. Time to Maximal Concentration in the Maternal Serum. [ Time Frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.

  3. Maximal Amlodipine Maternal Serum Concentration [ Time Frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.

  4. Half-life of Amlodipine in Maternal Plasma [ Time Frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The half-life of amlodipine in the maternal plasma in the peripartum period was measured.

  5. Clearance Rate of Plasma Amlodipine [ Time Frame: Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The clearance rate of amlodipine from the maternal plasma was measured.

  6. 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 ]
    Maternal and cord blood amlodipine levels/concentrations will be determined.

  7. Amlodipine Concentration in Breastmilk [ Time Frame: Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing ]
    The concentration of amlodipine besylate was measured in breastmilk samples.

  8. Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration) [ Time Frame: Infant blood sample drawn at approximately 36 hours of life ]
    Infant amlodipine level/concentration will be determined.


Secondary Outcome Measures :
  1. Neonatal Birth Weight [ Time Frame: Neonatal weight at the time of birth. ]
    The neonatal weight at birth was collected.

  2. Infant Gestational Age at Delivery. [ Time Frame: Gestational age at the time of birth ]
    The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.

  3. Infant Length of Stay. [ Time Frame: Time from birth to hospital discharge ]
    The length of stay of infants born to women taking amlodipine besylate will be collected.

  4. Major Infant Complications [ Time Frame: During neonatal hospitalization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353806


Locations
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United States, Texas
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Center for Advancing Translational Science (NCATS)
Investigators
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Principal Investigator: Jamie L Morgan, MD University of Texas Southwestern Medical Center

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Responsible Party: Jamie Morgan, Maternal Fetal Medicine Fellow, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02353806    
Other Study ID Numbers: 042014-059
UL1TR001105 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2015    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019
Last Verified: January 2019
Keywords provided by Jamie Morgan, University of Texas Southwestern Medical Center:
Amlodipine besylate
Breast milk
Pharmacokinetics
Chronic hypertension
Pregnancy
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents