Back to resultsEplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects
Primary Purpose
Ascites, Cirrhosis
Status
Withdrawn
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
About this trial
This is an interventional treatment trial for Ascites
Eligibility 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
Sites / Locations
- University Hospital of Skane
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eplerenone
Spironolactone
Arm Description
oral daily treatment with doses 100 to 400 mg
oral daily treatment with doses 100 to 400 mg
Outcomes
Primary Outcome Measures
Ascites
Secondary Outcome Measures
Full Information
NCT ID
NCT01801228
First Posted
February 26, 2013
Last Updated
January 14, 2016
Sponsor
Emma Nilsson
Collaborators
Göteborg University, Uppsala University Hospital, Karolinska University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County
1. Study Identification
Unique Protocol Identification Number
NCT01801228
Brief Title
Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects
Official Title
Swedish, Multicentered, Randomized Study of Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis Regarding Efficacy and Side Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Withdrawn
Why Stopped
difficulties to include patients
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emma Nilsson
Collaborators
Göteborg University, Uppsala University Hospital, Karolinska University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites, Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eplerenone
Arm Type
Experimental
Arm Description
oral daily treatment with doses 100 to 400 mg
Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
oral daily treatment with doses 100 to 400 mg
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Primary Outcome Measure Information:
Title
Ascites
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital of Skane
City
Lund
State/Province
Skane
ZIP/Postal Code
221 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects
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