Clinical trial NCT01386372 (phase 2, status: terminated)
Conditions: hyponatremia
ICD codes: P74.22, E87.1
Drugs: tolvaptan
SMILES: CC1=CC=CC=C1C(=O)NC1=CC(C)=C(C=C1)C(=O)N1CCC[C@@H](O)C2=C1C=CC(Cl)=C2
Reason stopped: 
    futility
  
Eligibility criteria:

        Inclusion Criteria:

          -  Non artifactual hyponatremia in euvolemic or hypervolemic states, defined as serum
             sodium <135 mEq/L confirmed in at least 2 consecutive evaluations;

          -  18 years of age or older;

          -  Able to give written 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 prior to the potential study enrollment, excluding
             percutaneous coronary interventions;

          -  History of a myocardial infarction within 30 days prior to the potential study
             enrollment;

          -  History of sustained ventricular tachycardia or ventricular fibrillation within the
             last 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;

          -  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;

          -  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.