E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003445 |
E.1.2 | Term | Ascites |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To describe the long-term control of ascites and maintenance of serum sodium with satavaptan compared to placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit (2 weeks after last dose) of last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |