Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

NCT02353806 | Completed Phase 4 Results

• 2 other identifiers: 042014-059UL1TR001105
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hypertension in Pregnancy

Keywords

Amlodipine besylate; Breast milk; Pharmacokinetics; Chronic hypertension; Pregnancy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Secondary Outcomes (4)

• Neonatal Birth Weight

  Neonatal weight at the time of birth.

• Infant Gestational Age at Delivery.

  Gestational age at the time of birth

• Infant Length of Stay.

  Time from birth to hospital discharge

• Major Infant Complications

  During neonatal hospitalization

Study Arms (1)

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.

Drug: Amlodipine besylate

Interventions

Amlodipine besylate DRUG

Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.

Pregnant women taking amlodipine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known kidney disease
• Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
• Administration of greater than 5 mg of amlodipine in 24 hour period

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jamie Morgan, MD
• Organization: University of Texas Southwestern Medical Center

jamie.morgan@utsouthwestern.edu

214-645-3838

Study Officials

• Jamie L Morgan, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 3, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 6, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-01

Locations

US (1)