Amlodipine vs Nifedipine ER for Hypertension
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.12345Why 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.678910
Who Is on the Research Team?
Katelyn Pratt, MD
Principal Investigator
Prisma Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Amlodipine or Nifedipine ER for management of postpartum hypertension
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amlodipine
- NIFEdipine ER
Amlodipine is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Hypertension
- Angina
- Variant angina
- Hypertension
- Coronary artery disease
- Variant angina
- Hypertension
- Angina
- Hypertension
- Angina pectoris
- Hypertension
- Hypertension
- Coronary artery disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Prisma Health-Upstate
Lead Sponsor