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

Phase 2

Withdrawn

• Conditions: Ascites; Cirrhosis
• Interventions: Drug: Eplerenone

• Registration Number: NCT01801228
• Lead Sponsor: Emma Nilsson

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-02-28
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eplerenone	Eplerenone	oral daily treatment with doses 100 to 400 mg
Spironolactone	Eplerenone	oral daily treatment with doses 100 to 400 mg

Primary Outcome Measures

Name	Time	Method
Ascites	6 months

Trial Locations

Locations (1)

University Hospital of Skane; 🇸🇪 Lund, Skane, Sweden