Recent Updates
Recently added Catalysts

satavaptan

Phase 3

Ascites | Small molecule | Gastrointestinal |Sanofi|Last Updated: May 26, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment872

FDA Designations

No designations recorded

Clinical trial landscape

satavaptan · 5 trials · 4 indications

Phase 3 1Phase 2 4
NCT00358878Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)Ascites
COMPLETED463 Analytics
PHASE3COMPLETED
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
Ascites
NCT00358878463
Unlock trial analytics

Study Endpoints

Primary Endpoints

Composite endpoint of ascites worsening
at week 12
Time to repeat therapeutic paracentesis
12 weeks
Change in body weight
within 14 days
change in body weight, change in serum sodium
within 14 days
serum sodium concentration

Secondary Endpoints

Composite endpoint of ascites worsening
at week 24
Increase in ascites
at week 12
Increase in ascites judged by body weight and ascites volume
within 12 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SatavaptanEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SatavaptanDRUGoral administration once daily
placeboDRUGoral administration once daily
satavaptan (SR121463B)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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 ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileCroatiaDenmarkFranceHungaryIsraelItalyNetherlandsPolandPortugalRomaniaRussiaSpainSwedenUnited KingdomCzechiaGermanyTaiwan
Unlock Eligibility Criteria

Frequently asked questions about satavaptan

What is satavaptan used for?

Satavaptan is an investigational small molecule being developed for the Syndrome of Inappropriate ADH (SIADH) Secretion and ascites. It is being studied in patients with hyponatremia related to SIADH and in patients with cirrhotic ascites, including those with normal or low sodium levels.

Who makes satavaptan?

Satavaptan is being developed by Sanofi, a company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with SIADH and ascites.

What phase is satavaptan in?

Satavaptan is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All four completed trials listed for satavaptan are Phase 2 studies, and the drug is no longer in active clinical trials.

What clinical trials has satavaptan been in?

Satavaptan has been studied in four completed clinical trials. These include NCT00032734 in patients with SIADH, NCT00501384 for prevention of ascites, NCT00501566 in normonatremic patients with cirrhotic ascites, and NCT00501722 in hyponatremic patients with cirrhotic ascites. All trials were randomized, double-blind, and placebo-controlled.

Is satavaptan the same as SR121463B?

Yes, satavaptan is also known by the code name SR121463B. In clinical trial NCT00032734, the drug is referred to as SR121463B when studying its efficacy in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion.