Amlodipine Versus Nifedipine ER for the Management of Postpartum 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

175 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is the treatment generally safe for humans?

The treatment, including amlodipine and nifedipine, is generally considered safe for humans. Common side effects include swelling (edema), headache, and dizziness, but these are usually mild. Amlodipine has a favorable safety profile compared to other medications like beta-blockers and is well tolerated by elderly patients. ^{1 2 3 4 5}

How does the drug Amlodipine, NIFEdipine ER differ from other treatments for hypertension?

Amlodipine and NIFEdipine ER are both calcium channel blockers that help lower blood pressure by relaxing blood vessels, but Amlodipine is noted for its longer-lasting effects and better tolerance compared to NIFEdipine. This makes Amlodipine a preferred option for patients who need consistent blood pressure control with fewer side effects. ^{1 2 6 7 8}

Research Team

Katelyn Pratt, MD

Principal Investigator

Prisma Health

Eligibility Criteria

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

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

Treatment Details

Interventions

• Amlodipine
• NIFEdipine ER

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of dihydropyridine calcium channel blockers in African American patients with hypertension. ISHIB Investigators Group. International Society on Hypertension in Blacks. [2022]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

[Personal clinical experience in the treatment of arterial hypertension using amlodipine]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

The safety of amlodipine. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Calcium antagonists as first-line antihypertensive agents: a placebo-controlled, comparative trial of isradipine and nifedipine. [2013]

6. Italy pubmed.ncbi.nlm.nih.gov

[A comparison between amlodipine and nifedipine retard in patients with essential arterial hypertension]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Nisoldipine: a new dihydropyridine calcium-channel blocker. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[Long-term clinical study of a new molecule (nifedipine) in ischemic cardiopathy]. [2013]