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Amiloride for Prehypertension (SAPHA Trial)
SAPHA Trial Summary
This trial will test whether amiloride can improve vascular health in young adults with prehypertension.
SAPHA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAPHA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAPHA Trial Design
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Who is running the clinical trial?
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- I am either Caucasian or African-American.I am not pregnant, as confirmed by tests during screening.I am not on any blood pressure medications.My blood pressure is slightly high but not in the hypertension range.I do not have any major illnesses like diabetes or liver disease.Your HbA1C level is higher than 7.0% during the screening visit.My kidney function is reduced, with creatinine levels high or clearance low.My potassium levels are higher than 5.5 mEq/L.
- Group 1: Amiloride
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is eligibility for this trial restricted to individuals below a certain age?
"According to this medical study's rules of participation, the minimum age for enrolment is 18 with a maximum cutoff at 35."
Has this medical therapy been given the green light by federal regulators?
"This treatment has been approved and is thus given a score of 3 on our safety scale. As this is classified as a Phase 4 trial, it implies that the medication has gone through multiple rounds of testing to ensure its efficacy and safety."
Are there any other trials which have explored this therapy's efficacy?
"Presently, there are 7 clinical trials in progress for the medication under consideration. Two of these studies have advanced to Phase 3 status. Most sites hosting this trial are located around Salt Lake City, Utah; however, patient recruitment is also occurring at 6 other locations throughout the country."
What medical conditions is this treatment usually prescribed for?
"This particular treatment is primarily utilized to address hypertensive disease, yet its application may be extended towards other ailments such as nephrolithiasis, congestive heart failure (CHF), and polyuria."
Are there openings available for this research project at present?
"The trial in question is no longer accepting applications. It was initially posted on September 1st, 2010 and edited for the last time on October 22nd, 2012. However, 16 studies with prehypertension as a criteria are still looking to recruit patients and 7 trials concerning this treatment specifically are also recruiting enrollees."
How many subjects are being examined in this clinical experiment?
"This study is no longer accepting participants; its original post date was September 1st, 2010 and it most recently updated on October 22nd, 2012. Currently 16 trials are recruiting those with prehypertension while 7 clinical studies are actively enrolling patients for the specified treatment."
Could I be an appropriate candidate for this investigation?
"This medical trial is searching for 32 individuals aged 18 to 35 with prehypertension. To be eligible, applicants must have a systolic blood pressure between 120 and 139 mmHg or diastolic BP between 80 to 89 mmHg during the screening phase- measured manually three times at 10 minute intervals after 5 minutes of sitting calmly in a chair (with the average of last two readings taken into account). Additionally, participants must identify as either Caucasian or African-American, possess no major past/current illnesses such as diabetes or liver disease, and not consume any medication that impacts blood pressure levels."
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