Amlodipine vs Nifedipine ER for Hypertension

Overseen By Principal Investigator

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Prisma Health-Upstate

Must not be taking: Antihypertensives

Disqualifiers: Tachycardia, Allergy to medications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2-5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two medications, amlodipine and nifedipine ER, to determine which manages high blood pressure more effectively in women after childbirth. Amlodipine, commonly used for high blood pressure in the general population, might have fewer side effects. The trial seeks to determine if it is as effective as nifedipine ER, which is frequently used but has some limitations. Women who have given birth after 20 weeks and require medication for high blood pressure might be suitable candidates for this study. As a Phase 4 trial, this research involves FDA-approved treatments and aims to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that participants have not used antihypertensive medications before delivery, so if you are currently on such medications, you would not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that amlodipine has been tested for safety in over 11,000 patients across various clinical trials. It is a well-known medication for controlling high blood pressure and is generally considered safe. Most people tolerate it well, though some might experience side effects like dizziness or a warm, red feeling on the skin.

Nifedipine ER, another medication similar to amlodipine, is often used to manage high blood pressure in women after childbirth. Both medications are effective, but they can cause different side effects.

Although amlodipine has not been specifically studied for high blood pressure after childbirth, it is already approved for general use and is known to have fewer side effects than nifedipine ER. This makes it a promising option for women dealing with high blood pressure after giving birth. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Amlodipine and Nifedipine ER for postpartum hypertension because they offer distinct approaches to managing this condition. Most treatments for postpartum hypertension, like labetalol or hydralazine, focus on reducing blood pressure through beta-blocking or vasodilation, respectively. Amlodipine, on the other hand, is a calcium channel blocker that helps relax blood vessels, potentially offering a smoother blood pressure control without the rapid heart rate often seen with other medications. Nifedipine ER, also a calcium channel blocker, provides long-acting relief, which might mean fewer doses needed throughout the day, improving convenience and compliance for new mothers. These unique features make both treatments promising options that could enhance comfort and efficacy in managing postpartum hypertension.

What evidence suggests that amlodipine might be an effective treatment for postpartum hypertension?

Research has shown that amlodipine, one of the treatments in this trial, effectively treats high blood pressure, reducing it both day and night. Compared to some other treatments, amlodipine is linked to fewer heart problems, such as heart attacks and strokes. It is generally well-tolerated and often causes fewer side effects than similar drugs. Although researchers have not specifically studied amlodipine in women after childbirth, its success in managing high blood pressure suggests it might also work well for postpartum high blood pressure. Another treatment option in this trial is Nifedipine ER, which serves as an active comparator. ^{6 7 8 9 10}

Who Is on the Research Team?

Katelyn Pratt, MD

Principal Investigator

Prisma Health

Are You a Good Fit for This Trial?

Inclusion Criteria

Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia

Delivery at or beyond 20 weeks' gestation

Need for antihypertensive therapy, defined as blood pressure >/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure >160/110 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either Amlodipine or Nifedipine ER for management of postpartum hypertension

2-5 days

During hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amlodipine
• NIFEdipine ER

How Is the Trial Designed?

Group I: Amlodipine Experimental Treatment 1 Intervention

Group II: Nifedipine ER Active Control 1 Intervention

Amlodipine is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Norvasc for:

• Hypertension
• Angina
• Variant angina

Approved in European Union as Norvasc for:

• Hypertension
• Coronary artery disease
• Variant angina

Approved in Canada as Norvasc for:

• Hypertension
• Angina

Approved in Japan as Norvasc for:

• Hypertension
• Angina pectoris

Approved in China as Norvasc for:

• Hypertension

Approved in Switzerland as Norvasc for:

• Hypertension
• Coronary artery disease

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Published Research Related to This Trial

Amlodipine, assessed in a study of 4227 subjects, showed a slightly higher incidence of side effects compared to placebo, primarily due to well-tolerated edema, but had a favorable safety profile compared to beta-blockers like atenolol and nadolol, with severe side effects being about half as common.

Amlodipine is well tolerated in elderly patients and does not negatively affect serum creatinine, urate, or glucose levels, making it a safe option for managing hypertension without the adverse effects seen with some other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of amlodipine. Osterloh, I.[2019]

In a study involving 3972 patients with mild to moderate essential hypertension, nifedipine demonstrated significant efficacy, with 66.5% of patients achieving a diastolic blood pressure of 90 mmHg or below after one month of treatment.

The safety profile of nifedipine showed expected side effects like flushing and headache, which decreased over time, while ankle edema persisted, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of nifedipine 20 mg tablets in hypertension using electronic data collection in general practice. Marley, JE.[2022]

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Amlodipine and Landmark Trials: A Review

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norliqva.com/resources/sds/

SDS

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SAFETY DATA SHEET

Ingestion of this material may cause effects similar to those seen in clinical use including abdominal pain, dizziness, flushing, heart ...

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2011/019787s047lbl.pdf

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NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. ... In vitro data indicate that NORVASC has no effect on ...

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MATERIAL SAFETY DATA SHEET

Statement of Hazard: Toxic to aquatic life. Additional Hazard Information: Short Term: May be harmful if swallowed. May cause eye irritation (based on ...

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mayoclinic.org

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Amlodipine (oral route) - Side effects & dosage

This medicine may cause worsening of angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check ...