An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-005239-25-HU
• Date of registration: 11/05/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Synthelabo Research
• Public title: An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety
• Scientific title: An open-label, multicenter study evaluating the long-term safety and efficacy of SR121463B in patients with Syndrome of Inappropriate Antidiuretic Hormone Secretion. - SIADH Safety
• Date of first enrolment: 06/07/2005
• Target sample size: 55
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005239-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, Hungary, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
• Male or female patients aged 18 years and higher
• SIADH
• Serum sodium between 115 mmol/L and 132 mmol/L
• Urinary osmolality > 200 mOsm/kg H2O
• Urinary sodium > 30 mmol/L
• Ability to give written informed consent (the informed consent form should 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 acute post operative SIADH
• Presence of dilutional hyponatremia in hypervolemic states (CHF and liver disease with Ascites)
• Presence of sign of hypovolemia
• Administration of other V2 receptor antogonists or demeclocycline or lithium within one month, thiazide diuretics or spironolactone within 15 days and urea or loop diuretics within 2 days prior to study drug administration.
• Presence of known treated or untreated adrenal deficiency
• Presence of untreated hypothyroidism
• Presence of uncontrolled diabetes with fasting glycemia > or equal to 200 mg/dL (> or equal 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
• Administration of inducers of CYP 3A4 (phenobarbital, phenytoin, rifampicine, Saint John's Wort) or potent or specific moderate inhibitors of CYP3A4. within 2 weeks prior to study drug administration
• QTcB = 500 ms




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

Health Condition(s) or Problem(s) studied

Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with serum sodium between 115 and 132 mmol/L.
MedDRA version: 7.1 Level: LLT Classification code 10040626

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: 5-

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-

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-

Primary Outcome(s)

Main Objective: to assess the long term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Secondary Objective: to assess the long term efficacy of SR121463B in maintaining normonatremia in patients with SIADH.

Primary end point(s): Serum sodium

Secondary ID(s)

CPR-SFY5904-EN-E01