Ascitis cirrótica. MedDRA version: 9.1 Level: LLT Classification code 10003445 Term: Ascites
Conditions
Sponsors
sanofi-aventis recherche et développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who completed a minimum of one year of study treatment in studies LTS5634 (ExpoCAT study) or LTS5635 (ExSPA study) - Who have no treatment discontinuation >7 days between discontinuation of the previous study and entering this study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Refusal or inability to give written informed consent to participate in the study • Serum potassium <3.5 mmol/l or =5.0 mmol/l • Serum magnesium <0.7 mmol/l • Haemodynamic insufficiency (e.g. systolic arterial pressure <80 mmHg or symptomatic orthostatic hypotension) • QTcF =480ms • Concomitant use of other vasopressin V2 receptor antagonist • Concomitant use of potent and selected moderate inhibitors of CYP 3A enzymes (aprepitant, atazanavir, chloramphenicol, clarithromycin, cremophor EL, cyclosporin, diltiazem, erythromycin, fluconazole, grapefruit juice, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil) • Known hypersensitivity to satavaptan or compounds with a similar chemical structure • Pregnant or breast-feeding women • Women of child-bearing potential are excluded unless they meet one of the following criteria: - Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test - Surgical sterilization for more than one month duration and a negative pregnancy test - Use of contraceptive intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test - Use of oral contraceptive in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of continued long-term treatment with satavaptan compared to placebo in patients with cirrhotic ascites already treated for a minimum of one year.;Secondary Objective: To describe the long-term control of ascites and maintenance of serum sodium with satavaptan compared to placebo.;Primary end point(s): There is no primary endpoint as the main objective of the study is to evaluate safety. Safety parameters will be assessed over the whole duration of the study. For the exploration of efficacy the endpoints recorded throughout the study will be • Paracentesis • Diuretic use • Serum sodium (in the case of hyponatraemia subjects) | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Spain
Outcome results
None listed