CLINICAL TRIAL

Amlodipine for Hypertension

Recruiting · 18+ · Female · Greenville, SC

This study is evaluating whether amlodipine is as effective as nifedipine ER in managing blood pressure in postpartum women.

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About the trial for Hypertension

Eligible Conditions
Hypertension · Hypertension, Pregnancy-Induced · Hypertension in Pregnancy

Treatment Groups

This trial involves 2 different treatments. Amlodipine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Amlodipine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
NIFEdipine ER
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
FDA approved

Side Effect Profile for Aim 1- Low Sodium

Aim 1- Low Sodium
Show all side effects
Headache
7%
viral illness
4%
Dizziness/Lightheadedness
4%
numbness
4%
Low glucose
4%
Nausea
4%
Cramp
0%
IV infiltration or malfunction
0%
discomfort with swallowing pill
0%
Pain
0%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT02034435) in the Aim 1- Low Sodium ARM group. Side effects include: Headache with 7%, viral illness with 4%, Dizziness/Lightheadedness with 4%, numbness with 4%, Low glucose with 4%.

Eligibility

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
must be You must be at least 18 years old to sign up. show original
is not recommended because there is limited evidence on which to base a recommendation The recommendation against delivery at or beyond 20 weeks' gestation is based on limited evidence. show original
are at risk for developing postpartum eclampsia show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through hospital stay, on average 2-5 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through hospital stay, on average 2-5 days.
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Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Amlodipine will improve 1 primary outcome and 6 secondary outcomes in patients with Hypertension. Measurement will happen over the course of until 6 weeks postpartum.

Number of patients reporting satisfaction with breastfeeding experience on patient-completed questionnaire
UNTIL 6 WEEKS POSTPARTUM
Breastfeeding duration
UNTIL 6 WEEKS POSTPARTUM
Number of patients requiring hospital readmission
UNTIL 6 WEEKS POSTPARTUM
Number of side effects reported by patient
THROUGH HOSPITAL STAY, ON AVERAGE 2-5 DAYS
Number of patients discontinuing medication due to side effects
THROUGH HOSPITAL STAY, ON AVERAGE 2-5 DAYS
Length of stay
THROUGH HOSPITAL STAY, ON AVERAGE 2-5 DAYS
length of stay from delivery until discharge
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hypertension?

Most patients were able to discontinue antihypertensive drugs, but many required ongoing medications for some time. In primary care settings, it may be difficult to treat hypertension among adults who are overweight, obese, have high blood pressure, or who are elderly.

Anonymous Patient Answer

Can hypertension be cured?

Hypertension cannot be cured. The medication will not reduce the blood pressure to normal levels even if treatment is successful. The patient cannot be cured.

Anonymous Patient Answer

What is hypertension?

One in five people in the United States have hypertension, as defined by the American Heart Association, American College of Cardiology and the National Institute of Health and Clinical Excellence. In the United States, an estimated $36.7 billion was spent in 2002 on antihypertensive drugs alone.\n

Anonymous Patient Answer

What are the signs of hypertension?

There are many signs of hypertension in adults, such as: shortness of breath, leg swelling, lightheadedness, blurred vision and feeling tired. There may also be more long term complications of hypertension such as coronary heart disease and peripheral arterial disease.

Anonymous Patient Answer

How many people get hypertension a year in the United States?

Nearly one fifth of U.S. adults (22.3 million) get hypertension. And about a quarter of those who get it develop chronic hypertension, and the average age at onset is 55 years.

Anonymous Patient Answer

What causes hypertension?

Most cases of hypertension are caused by excess salt, nicotine and alcohol intake in combination with an increase in peripheral resistance of arteries due to atherosclerosis and diabetes. In contrast, chronic psychological stress may play an important role in generating hypertension, especially in female tobacco smokers. This is likely due to psychological stress-induced alterations of the central nervous system and endocrine system in smokers who tend to develop hypertension. In the long term, psychological stress may induce alterations in the sympathetic nervous system, so that the sympathetic nervous system is unable to reduce blood pressure. In the short term, the effects of psychological stress can aggravate a high blood pressure crisis, often due to severe mental stress. The association of anxiety and mental stress with hypertension requires further investigation.

Anonymous Patient Answer

What is the primary cause of hypertension?

When comparing the results, no significant relationship was found between the different factors of the primary cause of hypertension like blood pressure, kidney function, and the type of the first symptoms. A significant relationship was however, found between hyperlipidemia and hypertension.

Anonymous Patient Answer

Have there been any new discoveries for treating hypertension?

Recent advances in hypertensive research are largely directed towards two goals: 1) the development or refinement of safe, long-acting agents that will lower blood pressure or eliminate it altogether; and 2) increased knowledge of the pathophysiology of hypertension through enhanced animal diagnostic and therapeutic strategies. The most widely used therapies for the treatment of hypertension today are ACE inhibitors and β-AR blockers. Several factors must be considered in deciding which agent(s) should be utilized: drug availability, adverse reaction profiles, and patient tolerability; costs; potential side effects; compliance; and the need for treatment modification based on dynamic changes in hypertension.

Anonymous Patient Answer

What is the average age someone gets hypertension?

Over 75% of those affected by hypertension in Singapore are diagnosed in their 40s and 50s. The first onset of hypertension is not associated with advancing age and a number of risk factors are independent of age at diagnosis. Smoking and family history of hypertension are strong risk factors while obesity was found to be moderately associated. Other salient characteristics of younger hypertensive patients include the presence of retinopathy and diabetic nephropathy at lesser degrees as well as high insulin resistance and hyperlipidemia that may be related to a combination of both, with more extensive risk factor involvement in the later two.

Anonymous Patient Answer

What is amlodipine?

Amlodipine is one of the most used lipid-sensitive calcium-channel blockers in the USA. Amlodipine has the unique characteristic of its dihydrochloride salt (Lipitor) not being a sympathomimetic drug. Amlodipine has been shown in randomized controlled clinical settings to have comparable or better therapeutic effects with less adverse effects than the dihydrochlorinated β antagonists.

Anonymous Patient Answer

Who should consider clinical trials for hypertension?

There are four groups of patients, namely: 1) patients who already self-treat, 2) patients who seek treatment but not yet self-treat, 3) those who are 'treatment intolerant', and those who do not want medical treatment. The first group of patients is willing to be 'treated without restriction'. The second group shows a significant interest in the treatment. But the third group shows no interest in treatment. And, finally, the 'treatment intolerant' group is almost nonexistent.

Anonymous Patient Answer

What are the latest developments in amlodipine for therapeutic use?

For the first time ever, amlodipine will be available in the US under the brand name of Omnicefy®. This new, patented tablet is based on a novel formulation technology developed by Oasis Therapeutics and combines enhanced bioavailability and extended duration of efficacy with the convenience of once-daily sublingual administration. Omnicefy® is designed to be taken at home to facilitate self-management and is intended to boost the number of patients who can achieve targets for blood pressure control from traditional medications. Oasis Therapeutics anticipates initiating the Omnicefy® product registration (U. S. registration) in the first quarter of 2007. Please visit www.omnicefy.

Anonymous Patient Answer
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