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Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

NCT04790279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2024-10-28

Study results available
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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.

Conditions

  • Hypertension in Pregnancy

Interventions

DRUG

Amlodipine

Initiation of amlodipine 2.5 mg

DRUG

NIFEdipine ER

Initiation of nifedipine ER 30 mg

Sponsors & Collaborators

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Katelyn Pratt, MD · Prisma Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-12-13
Completion
2023-01-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790279 on ClinicalTrials.gov