The Effect of Amiloride and Spironolactone in Patients With Hypertension

NCT ID: NCT01388088

Last Updated: 2012-03-28

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

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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The investigators wish to investigate the potential effects of potassium. In this study we will examine patients with hypertension and increase their potassium-levels using Amiloride and Spironolactone.

The investigators will examine the changes in the cardiovascular system using a Sphygmocor-scanner.

Detailed Description

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Purpose of the study is to examine the effect of amilorid and spironolacton on

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
2. Pulsewavevelocity, augmentation index and centralt bloodpressure,
3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
4. Ambulatory blood pressure

Conditions

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Hypertension

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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Spironolactone

Increases the level of potassium

Group Type ACTIVE_COMPARATOR

Spironolactone

Intervention Type DRUG

25 mg twice a day

Amiloride

Increases the level of potassium

Group Type ACTIVE_COMPARATOR

Amiloride

Intervention Type DRUG

5 mg twice a day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice a day

Interventions

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Spironolactone

25 mg twice a day

Intervention Type DRUG

Amiloride

5 mg twice a day

Intervention Type DRUG

Placebo

twice a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypertension
* Age 45-70
* BMI: 18,5-30

Exclusion Criteria

* Other diseases
* Drug or alcohol abuse
* Abnormal findings in the screening procedure
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erling Bjerregaard Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

Proffesor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Solveig K Matthesen, Cand.Med

Role: PRINCIPAL_INVESTIGATOR

Medical Research Department

Locations

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Department of Medical Research

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MED.RES.HOS.2010.02.SKM

Identifier Type: -

Identifier Source: org_study_id

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