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

NCT01801228 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

  • Ascites
  • Cirrhosis

Interventions

DRUG

Eplerenone

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER
  • Uppsala University Hospital

    collaborator OTHER
  • Karolinska University Hospital

    collaborator OTHER
  • University Hospital, Linkoeping

    collaborator OTHER
  • University Hospital, Umeå

    collaborator OTHER
  • Region Örebro County

    collaborator OTHER
  • Emma Nilsson

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01801228 on ClinicalTrials.gov