A single-blind, placebo-controlled, multicentre study evaluating continued long-term treatment with satavaptan (SR121463B) in patients with ascites due to liver cirrhosis who have previously been treated in studies LTS5634 or LTS5635. - PASCCAL-1
- Conditions
- Cirrhotic AscitesMedDRA version: 9.1Level: LLTClassification code 10003445Term: Ascites
- Registration Number
- EUCTR2006-005753-29-CZ
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>For the exploration of efficacy the endpoints recorded throughout the study will be<br>• Paracentesis<br>• Diuretic use<br>• Serum sodium (in the case of hyponatraemia subjects)
- Secondary Outcome Measures
Name Time Method