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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

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE February 3, 2015
Results First Submitted Date  ICMJE November 28, 2018
Results First Posted Date  ICMJE February 6, 2019
Last Update Posted Date February 6, 2019
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
  • 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 ]
    The following pharmacokinetic parameters will be assessed: elimination half-life, time to peak serum concentration, maximal concentration, volume of distribution and area under the curve
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Neonatal Birth Weight [ Time Frame: Neonatal weight at the time of birth. ]
    The neonatal weight at birth was collected.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2015)
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 ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Official Title  ICMJE Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hypertension in Pregnancy
Intervention  ICMJE Drug: Amlodipine besylate
Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.
Study Arms  ICMJE 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.
Intervention: Drug: Amlodipine besylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2015)
15
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353806
Other Study ID Numbers  ICMJE 042014-059
UL1TR001105 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamie Morgan, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Center for Advancing Translational Science (NCATS)
Investigators  ICMJE
Principal Investigator: Jamie L Morgan, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP