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Calcium Channel Blocker

Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension

Phase 4
Waitlist Available
Research Sponsored by Prisma Health-Upstate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through hospital stay, on average 2-5 days
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial aims to determine if amlodipine is as effective as nifedipine ER in managing high blood pressure in postpartum women. Amlodipine is known for having fewer side effects and works by widening blood vessels to improve blood flow. Amlodipine is a long-acting calcium antagonist that effectively lowers blood pressure in patients with essential hypertension.

Eligible Conditions
  • Pregnancy-Induced Hypertension (PIH)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospital stay, on average 2-5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospital stay, on average 2-5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of Stay
Secondary study objectives
Patient Reported Side Effects

Side effects data

From 2019 Phase 4 trial • 44 Patients • NCT02034435
7%
Headache
4%
numbness
4%
Dizziness/Lightheadedness
4%
viral illness
4%
Low glucose
4%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aim 1- Low Sodium
Aim 2- Amlodipine
Aim 2- Eplerenone
Aim 1- High Sodium

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AmlodipineExperimental Treatment1 Intervention
Group II: Nifedipine ERActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
FDA approved

Find a Location

Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor
86 Previous Clinical Trials
43,651 Total Patients Enrolled
1 Trials studying Hypertension
202 Patients Enrolled for Hypertension
Katelyn Pratt, MDStudy ChairPrisma Health
~37 spots leftby Dec 2025
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