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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	9 October 2012
Main ID:	EUCTR2007-007941-10-HU
Date of registration:	12/06/2008
Prospective Registration:	Yes
Primary sponsor:	sanofi-aventis recherche et développement
Public title:
Scientific title:	A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) - AQUARIST I
Date of first enrolment:	04/08/2008
Target sample size:	129
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007941-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Belgium	France	Germany	Hungary

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
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Affiliation:

Key inclusion & exclusion 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 <275 mOsm/kg H2O, urine osmolality >100 mOsm/kg H2O, and urinary sodium >30 mmol/L at time of screening.
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:
-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 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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Dilutional hyponatraemia. MedRA term "HYPONATRAEMIA"
MedDRA version: 9.1 Level: LLT Classification code 10021036 Term: Hyponatraemia

Intervention(s)

Product Name: satavaptan
Product Code: SR121463B
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: satavaptan
CAS Number: 308145-17-7
Current Sponsor code: SR121463B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: satavaptan
Product Code: SR121463B
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: satavaptan
CAS Number: 308145-17-7
Current Sponsor code: SR121463B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the efficacy of satavaptan 10 and 25 mg/Day vs. placebo in correcting hyponatremia at Day 5 (pre-dose) in patients with dilutional hyponatremia due to SIADH

Primary end point(s): Serum sodium change from baseline at Day 5 (pre-dose)

Secondary Objective: To assess the safety of satavaptan versus placebo, as well as the maintenance of corrected serum sodium, the clinical outcome, quality of life, and health economic parameters in patients treated with satavaptan at Days 5 and 30.

Secondary Outcome(s)

Secondary ID(s)

EFC10102

2007-007941-10-DE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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