AscitesPhase 2Hypo~CATNCT00501722
Satavaptan Dose-Ranging Study in Hyponatraemic Patients With Cirrhotic Ascites
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 13 sites in 13 countries.
Trial summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Liver Cirrhosis
- What is being tested?
- satavaptan (SR121463B)
- How many people
- 110 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Apr 2004to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
- Moderate or tense ascites
- Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).
- Conditions
- Ascites, Liver Cirrhosis
- Being tested
- satavaptan (SR121463B)
- Keywords
- cirrhotic ascites, hyponatraemia
- Medical subject headings
- Ascites, Liver Cirrhosis, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satavaptan (SR121463B)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in body weight, change in serum sodium
Measured: within 14 days
Secondary outcomes (3)
abdominal girth and discomfort
Measured: 14 days
paracentesis
Measured: 14 days
trail-making test and quality of life
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startApr 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501722
- Sponsor's protocol ID
- DFI4521
- Other IDs
- LTS5634, LTS10209
- Acronym
- Hypo~CAT
- Status last verified
- Jan 2009
- First submitted
- 13 Jul 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gines P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D; HypoCAT Study Investigators. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008 Jul;48(1):204-13. doi: 10.1002/hep.22293.
PubMed 18508290
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study
- ClinicalTrials.gov ID
- NCT00501722
- Acronym / sponsor ID
- Hypo~CAT / DFI4521
- Conditions
- Ascites, Liver Cirrhosis
- Keywords
- cirrhotic ascites, hyponatraemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.
This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
- Moderate or tense ascites
- Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| satavaptan (SR121463B) | Drug | – |
Primary outcome
change in body weight, change in serum sodium
Time frame: within 14 days
3 secondary outcomes
abdominal girth and discomfort
Time frame: 14 days
paracentesis
Time frame: 14 days
trail-making test and quality of life
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
- Derived from this study: PubMed 18508290Gines P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D; HypoCAT Study Investigators. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008 Jul;48(1):204-13. doi: 10.1002/hep.22293.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Argentina, Australia, Belgium, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in body weight, change in serum sodium (time frame: within 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2009.