CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 175 enrolled
Drug / intervention
Amlodipine +1 moredrug
Likely dose
Amlodipine 2.5 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.

Search/NCT04790279
NCT04790279Phase 4Completed

Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension: A Randomized Controlled Noninferiority Trial

Prisma Health-Upstate·interventional·Posted Mar 10, 2021·Updated Oct 28, 2024

In Brief

A Phase 4 clinical trial evaluating Amlodipine and NIFEdipine ER for Hypertension in Pregnancy. Completed, enrolled 175 participants across 1 site.

Detailed Summary

A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 10, 2021
Enrollment StartApr 9, 2021
Primary CompletionDec 13, 2022
Study CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.3 years ago

Interventions

Amlodipinedrug

Initiation of amlodipine 2.5 mg

NIFEdipine ERdrug

Initiation of nifedipine ER 30 mg