NCT00366795|TerminatedPhase 3

Study Stopped

Study was terminated due to safety reason.

Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

SPARe-2

Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC6682EudraCT : 2006-000132-27LTS10036

Study Type

interventional

Target

241

Locations

21 countries

Sites

Timeline

RegisteredAug 2006

StartedAug 2006

CompletionDec 2008

Brief Summary

Primary: To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites. Secondary: To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

241

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Aug 2006

Geographic Reach

21 countries

21 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

August 1, 2006

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

Last Updated

May 18, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

August 18, 2006

Last Update Submit

April 18, 2016

Conditions

Ascites Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

Number and time of recurrences of therapeutic paracenteses
up to 12 weeks

Secondary Outcomes (2)

Time from randomisation to first recurrence of ascites
study period
Increase in ascites
over 12 weeks

Study Arms (2)

Satavaptan

EXPERIMENTAL

Drug: Satavaptan

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

SatavaptanDRUG

oral administration once daily

Also known as: SR121463B

Satavaptan

placeboDRUG

oral administration once daily

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with cirrhosis of the liver.
Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
Patients with recurrent ascites having undergone both of the following:
therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or \> 4 litres of fluid.
at least one other therapeutic paracentesis in the previous 3 months.

You may not qualify if:

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

Contact the study team to confirm eligibility.