Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients With Dilutional Hyponatremia
Brief Summary: Primary:

* To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis

Secondary:

* To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients
* To assess the safety and tolerability of SR121463B


Options:
A: Inclusion Criteria:

* Male or Female patients aged 18 higher
* Dilutional Hyponatremia with serum sodium between 115 and 132 mmol/L
* Ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)

Exclusion Criteria:

* Presence of known or untreated adrenal insufficiency, SIADH or cirrhosis, or hyperthyroidism
* 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 ³ 200 mg/dL (³ 11.09 mmol/L)
* Patients considered by the Investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the Investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious)
* Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
* Presence or history of allergic reaction to SR121463B8
* Previous study with SR121463B
* Inadequate hematological, renal, and hepatic functions: hemoglobin (Hb) \< 9 g/dL, neutrophils \< 1,500/mm3, platelets \< 100,000/mm3, serum creatinine \> 175 mol/L (or clearance of creatinine \< 30 mL/min for sites where Ethics Committees require this parameter), serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN)
* QTCB 500 ³ ms
* Positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential
* Pregnancy or breast-feeding
B: Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination, or biochemical evidence
* Moderate or tense ascites
* Patients with hyponatremia, defined as a serum sodium concentration of ≤130 mmol/L

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
C: Inclusion Criteria:

* Grade 2 ascites
* Serum creatinine less than 1.2 mtg/dl
* Serum sodium \> 130 mmol/l
* Serum potassium within 3.5 and 4.5 mmol/l
* At least five days after the withdrawal of diuretics
* A 90 mmol/day Na diet.

Exclusion Criteria:

* Any therapeutic paracentesis for ascites before inclusion
* Cardiac or respiratory disease
* Gastrointestinal bleeding, hepatic encephalopathy, bacterial infections in the last 4 weeks before inclusion.
* The use of NSAIDs or other nephrotoxic drugs in the last 4 weeks before inclusion.
D: Inclusion Criteria

* Hyponatremia in euvolemic or hypervolemic states, defined as serum sodium \<135 mEq/L prior to randomization.
* Able to give Informed Consent

Exclusion Criteria

* Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
* Hyponatremia in hypovolemic states.
* Acute and transient hyponatremia associated with head trauma or post-operative state.
* Hyponatremia due to uncontrolled hypothyroidism or uncontrolled adrenal insufficiency.
* Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
* History of a myocardial infarction within 30 days of potential study enrollment.
* History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
* Severe angina including angina at rest or at slight exertion and/or unstable angina.
* History of a cerebrovascular accident within the last 30 days. 10) Subjects with psychogenic polydipsia may not be included, however subjects with other psychiatric illness may be included.
* Systolic arterial blood pressure \<90 mmHg.
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril).
* History of drug or medication abuse within the past year,or current alcohol abuse.
* Uncontrolled diabetes mellitus defined as fasting glucose \>300mg/dL.
* Urinary tract obstruction except BPH if non-obstructive.
* Previous participation in another clinical drug trial within the past 30 days.
* Previous participation in this or any other tolvaptan clinical trial.
* Terminally ill or moribund condition with little chance of short term survival.
* Serum creatinine \>3.5 mg/dL.
* Serum sodium \<120 mEq/L with associated neurologic impairment, i.e. symptoms such as apathy, confusion, seizures.
* Patients with progressive or episodic neurologic disease such as multiple sclerosis or history of multiple strokes.
* Child-Pugh score greater than 10 (unless approved)
* Patients receiving intravenous fluids at a rate greater than KVO (Keep Vein Open).
* Hyponatremia due to lab artifacts
* Patients receiving AVP or its analogs for treatment of any condition.
* Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea
* Patients likely requiring IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study.
* Severe pulmonary artery hypertension
* Hyponatremia should not be the result of any medication that can safely be withdrawn

Answer: A