At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 16 enrolled
Drug / intervention
Amlodipine besylatedrug
Likely dose
Amlodipine besylate 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
University of Texas Southwestern Medical Center·interventional·Posted Feb 3, 2015·Updated Feb 6, 2019
In Brief
A Phase 4 clinical trial evaluating Amlodipine besylate for Chronic Hypertension in Pregnancy. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hypertension in Pregnancy
CountriesUnited States
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedFeb 2015
Primary CompletionJul 2016
Study CompletionSep 2016
TodayJul 2026
First PostedFeb 3, 2015
Enrollment StartJan 1, 2015
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.4 years ago
Interventions
Amlodipine besylatedrug
Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.