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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Yanbin Dong, Georgia Health Sciences University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308983
First Posted: March 4, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanbin Dong, Georgia Health Sciences University
March 2, 2011
March 4, 2011
October 12, 2017
September 2010
December 2012   (Final data collection date for primary outcome measure)
Vascular phenotypes [ Time Frame: 16 weeks ]
(Flow mediated dilation, Pulse wave velocity, and carotid artery compliance)
Same as current
Complete list of historical versions of study NCT01308983 on ClinicalTrials.gov Archive Site
Not Provided
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Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension
Not Provided
Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prehypertension
Drug: Amiloride
Amiloride 10 mg orally once a day for 16 weeks
Amiloride
Intervention: Drug: Amiloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
32
Not Provided
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01308983
1000
Yes
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Yanbin Dong, Georgia Health Sciences University
Augusta University
Not Provided
Not Provided
Augusta University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP