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NCT00857909 Clinical Trial

The Effect of Amiloride and Spironolactone in Healthy Persons

High Blood Pressure Clinical Trial

— SPAS  

Official title:
The Effect of Amiloride and Spironolactone Measured on Cardiovascular and Kidney Related Variables in Healthy Subjects in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00857909
Other study ID # MED.RES:HOS:SKM.02.2009
Secondary ID
Status Completed
Phase Phase 1
First received March 6, 2009
Last updated July 7, 2011
Start date January 2009
Est. completion date July 2010

Study information
Verified date July 2011
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

This study will investigate whether retaining potassium in the body will lead to changes in blood pressure and changes in blood and urine samples.

Description:

The purpose is to measure the effect of amiloride and spironolactone on:

1. Renal function (GFR, u-AQP2, u-ENaCĪ², u-cAMP, u-PGE2, CH20, FENa, FEK),

2. Pulsbewave velocity, augmentation index and central blood pressure,

3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and

4. Ambulatory blood pressure

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy

- Non-smokers

Exclusion Criteria:

- Smoking

- Under medical treatment

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Amiloride
1 tablet twice a day
• Spironolactone
1 tablet twice a day
• Placebo
Placebo
• Placebo and spironolactone
5mg twice daily
• Spironolactone
25mg twice daily

Locations
Country Name City State
Denmark Medical Research Holstebro

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure 2 years No
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