- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308983
Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension (SAPHA)
October 22, 2012 updated by: Yanbin Dong, Augusta University
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samip J Parikh, MBBS, MPH
- Phone Number: 7067211764
- Email: sparikh@georgiahealth.edu
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Georgia Prevention Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Amiloride
|
Amiloride 10 mg orally once a day for 16 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular phenotypes
Time Frame: 16 weeks
|
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ANTICIPATED)
December 1, 2012
Study Registration Dates
First Submitted
March 2, 2011
First Submitted That Met QC Criteria
March 3, 2011
First Posted (ESTIMATE)
March 4, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 23, 2012
Last Update Submitted That Met QC Criteria
October 22, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Prehypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Channel Blockers
- Diuretics, Potassium Sparing
- Acid Sensing Ion Channel Blockers
- Epithelial Sodium Channel Blockers
- Amiloride
Other Study ID Numbers
- 1000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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