Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Completed NCT02551640 - Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients N/A
Recruiting NCT01483430 - Effect of Ginseol Kg1 on Blood Pressure Lowering Phase 3
Completed NCT01637909 - Korean Life-Style Modification Effects on Blood Pressure N/A
Terminated NCT01295216 - Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings N/A
Active, not recruiting NCT03596099 - Rice Vinegar as an Intervention to Lower Blood Pressure in Adults With Prehypertension and 10-year CVD Risk <10% N/A
Completed NCT04326686 - Measuring Individual Responses to a Wholegrains and Nuts Intervention to Reduce Blood Pressure in Prehypertension N/A
Completed NCT03898518 - The Effects of a Jump Rope Exercise Program on Body Composition and Self-efficacy in Obese Adolescent Girls N/A
Terminated NCT01983462 - Vascular Dysfunction in Human Obesity Hypertension Phase 2
Completed NCT01458496 - Health Coaching to Effect Lifestyle Behaviour Change N/A
Completed NCT01472692 - Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure Phase 4
Completed NCT03266510 - Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function N/A
Completed NCT02998840 - A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure Phase 2
Completed NCT01974570 - Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects Phase 2
Completed NCT02326766 - Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects Phase 3
Completed NCT01395329 - Nebivolol and the Endothelin (ET)-1 System Phase 4
Completed NCT01331486 - Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract Phase 1
Completed NCT05274971 - Diet and Exercise on Ambulatory Blood Pressure N/A
Active, not recruiting NCT02371317 - Stress Management for High Blood Pressure N/A
Completed NCT03006471 - Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and Prehypertension Phase 4