A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-003985-14-HU
• Date of registration: 13/04/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Synthelabo Research
• Public title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia
• Scientific title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Two Doses of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients with Dilutional Hyponatremia - Dilutional Hyponatremia
• Date of first enrolment: 23/05/2005
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003985-14
• 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: yes Other trial design description: double-blind followed by an open-label dose-adjustement phase If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Denmark, Hungary, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female patients aged 18 years and higher
• Dilutional hyponatremia with serum sodium between 115 and 132 mmol/L
• Ability to give a written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)
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:
• Patients with known treated or untreated adrenal insufficiency
• Patients with known SIADH or cirrhosis
• Presence of untreated hypothyroidism
• QTcB = 500 ms
• Presence of signs of hypovolemia
• Administration of other V2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration
• Presence of uncontrolled diabetes with fasting glycemia = 200 mg/dL (= 11.09 mmol/L)
• Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John’s Wort) or potent and specific moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
• Inadequate hematological, renal and hepatic functions
• Positive pregnancy test and absence of medically approved contraceptive methods for female of childbearing potential
• Pregnancy or breast-feading



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

Health Condition(s) or Problem(s) studied

Dilutional hyponatremia excluding chronic syndrome of inappropriate antidiuretic hormone secretion (SIADH) or cirrhosis
MedDRA version: 7.1 Level: LLT Classification code 10021038

Intervention(s)

Product Name: NA
Product Code: SR121463B
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 308145-17-7
Current Sponsor code: SR121463B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: NA
Product Code: SR121463B
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
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: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: To assess the long-term efficacy of SR121463B in maintaining normonatremia in patients with dilutional hyponatremia excluding chronic SIADH or cirrhosis and to assess the safety and tolerability of SR121463B in these patients.

Main Objective: To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia excluding known SIADH or cirrhosis.

Primary end point(s): Serum sodium

Secondary ID(s)

CPR-EFC5816-EN-E01