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The Effect of Amiloride and Spironolactone in Healthy Persons

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00857909
Acronym
SPAS
Enrollment
30
Registered
2009-03-09
Start date
2009-01-31
Completion date
2010-07-31
Last updated
2011-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure

Brief 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.

Detailed description

The purpose is to measure the effect of amiloride and spironolactone on: 1. Renal function (GFR, u-AQP2, u-ENaCβ, 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

Interventions

DRUGAmiloride

1 tablet twice a day

DRUGSpironolactone

1 tablet twice a day

DRUGPlacebo

Placebo

DRUGPlacebo and spironolactone

5mg twice daily

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Non-smokers

Exclusion criteria

* Smoking * Under medical treatment

Design outcomes

Primary

MeasureTime frame
Blood pressure2 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026