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

Emma Nilsson

Status and phase: Withdrawn; Phase 2

Conditions: Cirrhosis; Ascites

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT01801228

2011-001264-22 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Eplerenone

Experimental group

Description:

oral daily treatment with doses 100 to 400 mg

Treatment:

Drug: Eplerenone

Spironolactone

Active Comparator group

Description:

oral daily treatment with doses 100 to 400 mg

Treatment:

Drug: Eplerenone