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NCT01308983 Clinical Trial

Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

Prehypertension Clinical Trial

— SAPHA  

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01308983
Other study ID # 1000
Secondary ID
Status Unknown status
Phase Phase 4
First received March 2, 2011
Last updated October 22, 2012
Start date September 2010

Study information
Verified date October 2012
Source Augusta University
Contact Samip J Parikh, MBBS, MPH
Phone 7067211764
Email sparikh@georgiahealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.

Recruitment information / eligibility
Status Unknown status
Enrollment 32
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Amiloride
Amiloride 10 mg orally once a day for 16 weeks

Locations
Country Name City State
United States Georgia Prevention Institute Augusta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vascular phenotypes (Flow mediated dilation, Pulse wave velocity, and carotid artery compliance) 16 weeks
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