Clinical trial NCT01055912 (phase 2, status: completed)
Conditions: congestive heart failure
ICD codes: I50.20, I50.21, I50.22, I50.30, I50.31, I50.32, I50.40
Drugs: lixivaptan, placebo
SMILES: CC1=CC=C(F)C=C1C(=O)NC1=CC=C(C(=O)N2CC3=CC=CN3CC3=C2C=CC=C3)C(Cl)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand the purpose and risks of the study and to provide signed and
             dated informed consent.

          -  Men and women aged 18 years or older.

          -  History of chronic CHF defined as requiring standard HF treatment (including
             diuretics) for a minimum of 30 days.

          -  Documented LVEF by any method within 12 months prior to screening.

          -  The patient has clinical evidence of volume overload at the time of inclusion with at
             least one of the following:

               -  Dyspnea

               -  Pulmonary congestion (rales)

               -  Peripheral edema

               -  Increased jugular venous pressure and/or hepatic congestion with ascites

               -  Chest x-ray consistent with CHF

               -  Plasma brain natriuretic peptide (BNP) ≥150 pg/mL or N-terminal prohormone brain
                  natriuretic peptide (NT pro-BNP) ≥450 pg/mL

        Exclusion Criteria:

          -  Women who are pregnant (positive pregnancy test), breastfeeding, or who will not
             adhere to the reproductive precautions as outlined in this protocol and in the
             informed consent form (ICF).

          -  Sustained (three blood pressure measurements over 1 hour) systolic blood pressure <90
             mmHg at Screening or Day 0.

          -  ST segment elevation myocardial infarction or stroke within 30 days prior to
             Screening.

          -  Hemodynamically destabilizing cardiac arrhythmia within 30 days prior to Day 0.

          -  Clinically significant valvular disease.

          -  Known clinically significant obstructive, restrictive, or hypertrophic cardiomyopathy.

          -  Cardiac surgery or percutaneous coronary intervention within 30 days prior to Day 0.

          -  Major surgical procedure within 7 days prior to Day 0.

          -  Likely to undergo cardiac transplantation, left ventricular assist device (LVAD) or
             other device implantation, or other cardiac surgery within 3 months after Screening.

          -  Placement of implantable cardioverter defibrillator or cardiac resynchronization
             therapy device within 60 days prior to Day 0.

          -  CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid
             cardiomyopathy.

          -  Presence of any clinically significant (as determined by the Investigator)
             endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
             neurologic, dermatologic, psychiatric, oncologic, and/or other major disease that
             might interfere with safe and compliant participation in this study.

          -  Screening laboratory findings as follows:

               -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the
                  upper limit of normal

               -  Total bilirubin >2.0 mg/dL

               -  Serum creatinine >3.0 mg/dL

               -  Hemoglobin <9.0 g/dL

          -  Uncontrolled diabetes mellitus as defined by the Investigator (e.g., glycosylated
             hemoglobin [HbA1c] >9%).

          -  History of chronic drug/medication abuse within the past 6 months; or current alcohol
             abuse.

          -  Co-morbid condition with an expected survival of less than 3 months.

          -  Known allergy to any vasopressin antagonist or any condition for which treatment with
             a vasopressin antagonist may present undue risk to the patient.

          -  Current or recent administration (within 7 days of Day 0) of prohibited medications as
             listed in Section 8.6.4 .

          -  Participation in any other investigational study of drugs or devices within 30 days
             prior to Screening.