PrehypertensionPhase 4SAPHANCT01308983
Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
A Phase 4 study testing Amiloride in people with Prehypertension, run by Augusta University at 1 site in United States.
Trial summary
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
- Male or female of Caucasian or African-American origin.
- No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
- Not taking any medication that affects blood pressure.
Who cannot join
- HbA1C > 7.0 % during screening visit.
- Serum potassium > 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 50 ml/min* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
- Female having positive pregnancy test during screening and/or any testing visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Prevention Institute
Augusta, Georgia, 30912
Yanbin Dong, MD, PhD
About this study
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.
- Conditions
- Prehypertension
- Being tested
- Amiloride
- Keywords
- Prehypertension, Flow mediated dilation, Pulse wave velocity, carotid compliance, Prehypertension and amiloride
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
Amiloride 10 mg orally once a day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Other | Not described Receives: Drug: Amiloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular phenotypes
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Dong, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308983
- Sponsor's protocol ID
- 1000
- Acronym
- SAPHA
- Status last verified
- Oct 2012
- First submitted
- 2 Mar 2011
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhagatwala J, Harris RA, Parikh SJ, Zhu H, Huang Y, Kotak I, Seigler N, Pierce GL, Egan BM, Dong Y. Epithelial sodium channel inhibition by amiloride on blood pressure and cardiovascular disease risk in young prehypertensives. J Clin Hypertens (Greenwich). 2014 Jan;16(1):47-53. doi: 10.1111/jch.12218. Epub 2013 Oct 31.
PubMed 24410943
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
- ClinicalTrials.gov ID
- NCT01308983
- Acronym / sponsor ID
- SAPHA / 1000
- Conditions
- Prehypertension
- Keywords
- Prehypertension, Flow mediated dilation, Pulse wave velocity, carotid compliance, Prehypertension and amiloride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Other | Drug: Amiloride |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
- Male or female of Caucasian or African-American origin.
- No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
- Not taking any medication that affects blood pressure.
Key exclusion criteria (4 listed)
- HbA1C > 7.0 % during screening visit.
- Serum potassium > 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 50 ml/min* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
- Female having positive pregnancy test during screening and/or any testing visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmilorideAmiloride 10 mg orally once a day for 16 weeks | Drug | Amiloride |
Primary outcome
Vascular phenotypes
Time frame: 16 weeks
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- Derived from this study: PubMed 24410943Bhagatwala J, Harris RA, Parikh SJ, Zhu H, Huang Y, Kotak I, Seigler N, Pierce GL, Egan BM, Dong Y. Epithelial sodium channel inhibition by amiloride on blood pressure and cardiovascular disease risk in young prehypertensives. J Clin Hypertens (Greenwich). 2014 Jan;16(1):47-53. doi: 10.1111/jch.12218. Epub 2013 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amiloride in people with Prehypertension, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samip J Parikh, MBBS, MPH (7067211764, sparikh@georgiahealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular phenotypes (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.