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

Cirrhosis Clinical Trial

Official title:

Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01801228
• Other study ID #: 2011-001264-22
• Secondary ID: 2011-001264-22
• Status: Withdrawn
• Phase: Phase 2
• First received: February 26, 2013
• Last updated: January 14, 2016
• Start date: February 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Cirrhosis
• Liver Cirrhosis

Intervention

Drug:
• Eplerenone

Locations

Country	Name	City	State
Sweden	University Hospital of Skane	Lund	Skane

Sponsors (7)

Lead Sponsor	Collaborator
Emma Nilsson	Göteborg University, Karolinska University Hospital, University Hospital Orebro, University Hospital, Linkoeping, University Hospital, Umeå, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascites		6 months	No