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

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ClinicalTrials.gov Identifier: NCT01801228
Recruitment Status : Withdrawn (difficulties to include patients)
First Posted : February 28, 2013
Last Update Posted : January 15, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ascites Cirrhosis Drug: Eplerenone Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects
Study Start Date : February 2013
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Eplerenone
oral daily treatment with doses 100 to 400 mg
Drug: Eplerenone
Active Comparator: Spironolactone
oral daily treatment with doses 100 to 400 mg
Drug: Eplerenone


Outcome Measures

Primary Outcome Measures :
  1. Ascites [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801228


Locations
Sweden
University Hospital of Skane
Lund, Skane, Sweden, 221 85
Sponsors and Collaborators
Emma Nilsson
Göteborg University
Uppsala University Hospital
Karolinska University Hospital
University Hospital, Linkoeping
University Hospital, Umeå
Region Örebro County
More Information

Responsible Party: Emma Nilsson, Gastroenterologist, Region Skane
ClinicalTrials.gov Identifier: NCT01801228     History of Changes
Other Study ID Numbers: 2011-001264-22
2011-001264-22 ( EudraCT Number )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases
Spironolactone
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents