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

E

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Withdrawn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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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