The Effect of Amiloride and Spironolactone in Healthy Persons (SPAS)

R

Regional Hospital Holstebro

Status and phase

Completed
Phase 1

Conditions

High Blood Pressure

Treatments

Drug: Spironolactone
Drug: Placebo and spironolactone
Drug: Amiloride
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00857909
MED.RES:HOS:SKM.02.2009

Details and patient eligibility

About

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

Full description

The purpose is to measure the effect of amiloride and spironolactone on: Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK), Pulsbewave velocity, augmentation index and central blood pressure, Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and Ambulatory blood pressure

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy
  • Non-smokers

Exclusion criteria

  • Smoking
  • Under medical treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 3 patient groups, including a placebo group

Randomisation 1
Active Comparator group
Description:
Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo
Treatment:
Drug: Amiloride
Drug: Placebo and spironolactone
Randomisation 2
Active Comparator group
Description:
Spironolactone 25 mg twice daily, to be compared with placebo and amiloride
Treatment:
Drug: Spironolactone
Placebo
Placebo Comparator group
Description:
calcium tablet
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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