Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation

Completed · Phase 4

Conditions studied: Chronic Hypertension in Pregnancy

In brief

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.

Key facts

Study ID

NCT02353806

Run by

University of Texas Southwestern Medical Center

People needed

16

Starts

2015-01-01

Expected to finish

2016-09-01

Last updated by the study team

2019-02-06

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• Parkland Health and Hospital System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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