None listed
Conditions
Interventions
Group 1 Type of group
satavaptan 10 mg / day orally for 11 days of treatment
Group name:Group 3 Type of group
They will receive placebo similar to the test drug for 11 days
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Patients with symptomatic SIADH with chronic hyponatremia, defined as: presence of at least one clinical symptom related to hyponatremia within the past 3 months in medical history and/or at baseline, and serum sodium between 115 and 132 mmol/L on two consecutive measurements at least 48h apart before randomization (screening and baseline). • The diagnosis of SIADH needs to be supported by the laboratory criteria serum osmolality 100 mOsm/kg H2O, and urinary sodium >30 mmol/L at time of screening.
Exclusion criteria
Exclusion criteria: • Patients with symptomatic SIADH with chronic hyponatremia, defined as: presence of at least one clinical symptom related to hyponatremia within the past 3 months in medical history and/or at baseline, and serum sodium between 115 and 132 mmol/L on two consecutive measurements at least 48h apart before randomization (screening and baseline). • The diagnosis of SIADH needs to be supported by the laboratory criteria serum osmolality 100 mOsm/kg H2O, and urinary sodium >30 mmol/L at time of screening. • At the time of screening age < legal age of majority • Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor) • Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension) • Patients with adrenocortical insufficiency • Patients with hypothyroidism • Patients with known causes of transient SIADH (e.g. post-operative conditions, acute pneumonia, drug-induced and in whom the drug is likely to be discontinued during the study participation, etc.) • Patients with psychogenic polydipsia or beer potomania • Concomitant use of thiazid diuretics during the study • Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening • Serum potassium <3.5 mmol/L or ≥5.0 mmol/L at baseline • Serum magnesium below lower limit of normal range at baseline • Patients with impaired hepatic function or liver cirrhosis (Child-Pugh A-C) • Patients with congestive heart failure • Patients with severe renal insufficiency (creatinine clearance <30 mL/min estimated by Cockroft-Goult formula) at time of screening • Patients with myocardial infarction or cerebrovascular accident in the 3 months prior to the study • Patients with a history of instable angina pectoris • Patients with a history of ventricular arrhythmia • ECG QTcF interval ≥480 ms at baseline • Presence of signs of any other clinically significant abnormality according to the Investigator ECG recording (12-lead ECG) • Concomitant use of satavaptan, other vasopressin V2 receptor antagonist, demeclocycline, or lithium, within 1 month and urea from two Days prior to study drug administration • 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, theophylline, troleandomycin, verapamil, voriconazole), within 2 weeks prior to study drug administration • Concomitant use of drugs which have been associated with QT interval prolongation and possible risk of Torsades de Pointes as listed in Appendix B during the study • Refusal or inability to give informed consent to participate in the study • Participation in any clinical study within the last 30 Days or a period shorter than 5-times the half-life of the respective investigational product, whatever is longer • Previous participation in a clinical study with satavaptan • 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 les
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Blood will be obtained by venous puncture at each visit according to the graphic design of the study before taking the study treatment. The samples will be handled and sent to the central laboratory, according to the laboratory requirements indicated in the laboratory manual. Measure:Change of serum sodium from baseline to Day 5 (prior to dose) Timepoints:Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Blood will be obtained by venous puncture at each visit according to the graphic design of the study before taking the study treatment. The samples will be handled and sent to the central laboratory, according to the laboratory requirements indicated in the laboratory manual. Measure:Change in baseline serum sodium until prior to the dose at each planned visit Timepoints:at each planned visit ; Outcome name:Responders are defined as patients with serum sodium> 135 mmol / L and / or increase in serum sodium> 5 mmol / L from baseline Measure:Response on day 5 Timepoints:Day 5 ; Outcome name:Blood and urine samples will be obtained according to the graphic design of the study before ingesting the study treatment. Samples will be handled and sent to the central laboratory for laboratory requirements, and are indicated in the laboratory manual. The results will be reported as mOsm / kg H20. Measure:Change in serum osmolarity from baseline to Day 5 and Day 30 Timepoints:Day 5 and Day 30 | — |
Contacts
Public ContactSandra Mendez
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed