Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-10-31

Brief Summary

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This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.

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Detailed Description

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Conditions

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Ascites Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eplerenone

oral daily treatment with doses 100 to 400 mg

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Spironolactone

oral daily treatment with doses 100 to 400 mg

Group Type ACTIVE_COMPARATOR

Eplerenone

Intervention Type DRUG

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male Ascites Cirrhosis

\-

Exclusion Criteria

Prior treatment with aldosterone antagonist Uncontrolled heart disease or diabetes Current malignancy Current medication interacting with aldosterone antagonists

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No