The Effect of Amiloride and Spironolactone in Healthy Persons

NCT ID: NCT00857909

Last Updated: 2011-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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

Conditions

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High Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Randomisation 1

Amiloride 5 mg twice daily for 28 days, later compared with spironolactone and placebo

Group Type ACTIVE_COMPARATOR

Amiloride

Intervention Type DRUG

1 tablet twice a day

Placebo and spironolactone

Intervention Type DRUG

5mg twice daily

Randomisation 2

Spironolactone 25 mg twice daily, to be compared with placebo and amiloride

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

1 tablet twice a day

Spironolactone

Intervention Type DRUG

25mg twice daily

Placebo

calcium tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Amiloride

1 tablet twice a day

Intervention Type DRUG

Spironolactone

1 tablet twice a day

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Placebo and spironolactone

5mg twice daily

Intervention Type DRUG

Spironolactone

25mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Non-smokers

Exclusion Criteria

* Smoking
* Under medical treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Medical Research Department

Principal Investigators

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Erling B Pedersen, Prof

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital Holstebro

Locations

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Medical Research

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MED.RES:HOS:SKM.02.2009

Identifier Type: -

Identifier Source: org_study_id

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