Cirrhotic Ascites Treatment With Satavaptan in Patients W... | NCT00358878

Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jul 31, 2006

First Submission Date that Met QC Criteria

Jul 31, 2006

First Posted Date

Aug 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 26, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 26, 2016

Certification/Extension First Posted Date

May 26, 2016Estimated

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

May 26, 2016Estimated

Description Module

Brief Summary

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

463Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Satavaptan	Experimental		Drug: Satavaptan
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Satavaptan	Drug	oral administration once daily	Satavaptan	SR121463B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite endpoint of ascites worsening		at week 12

Secondary Outcomes

Measure	Description	Time Frame
Composite endpoint of ascites worsening		at week 24
Increase in ascites		at week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with cirrhosis of the liver
Participants with clinically evident ascites primarily managed by diet and/or diuretics
Stable treatment of ascites for at least the previous 2 weeks without paracentesis
Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
Known hepatocellular carcinoma
Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
Participants previously exposed to satavaptan in the past 12 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21836029	Derived	Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis

ID	Type	Description	Link
EudraCT : 2006-000132-27
LTS10036