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Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension (SAPHA)

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ClinicalTrials.gov Identifier: NCT01308983
Recruitment Status : Unknown
Verified October 2012 by Yanbin Dong, Georgia Health Sciences University.
Recruitment status was:  Recruiting
First Posted : March 4, 2011
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University

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

Condition or disease Intervention/treatment Phase
Prehypertension Drug: Amiloride Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Amiloride Drug: Amiloride
Amiloride 10 mg orally once a day for 16 weeks

Primary Outcome Measures :
  1. Vascular phenotypes [ Time Frame: 16 weeks ]
    (Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308983

Contact: Samip J Parikh, MBBS, MPH 7067211764 sparikh@georgiahealth.edu

United States, Georgia
Georgia Prevention Institute Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Yanbin Dong, MD, PhD         
Sponsors and Collaborators
Augusta University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanbin Dong, Professor, Department of Pediatrics, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01308983     History of Changes
Other Study ID Numbers: 1000
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Keywords provided by Yanbin Dong, Georgia Health Sciences University:
Flow mediated dilation
Pulse wave velocity
carotid compliance
Prehypertension and amiloride

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing