Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyponatremia With Normal Extracellular Fluid Volume

In brief

The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.

Key facts

Study ID

NCT00660959

Run by

CardioKine Inc.

People needed

106

Starts

2008-04-01

Last updated by the study team

2011-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Men or women aged 18 or older
• Diagnosis of euvolemic hyponatremia (120 ≤ Na+<130 mEq/L)
• Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment

You may not qualify if…

• Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
• Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)
• Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
• Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
• Hyponatremia as a result of any medication that can safely be withdrawn
• Hyponatremia due to hypothyroidism or adrenal insufficiency
• Diagnosis of psychogenic polydipsia
• Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan
• Use of radiotherapy and chemotherapy within 2 wks of randomization
• Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study
• Supine systolic arterial blood pressure of ≤ 90 mmHg
• Serum creatinine >3.0 mg/dL
• History of uncontrolled type 2 diabetes mellitus
• Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate with sudden shifts in fluid volumes and cardiac filling pressures
• Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
• History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening
• History of cerebral vascular accident (CVA) within 60 days prior to screening
• Established diagnosis of nephrotic syndrome
• Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
• Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive)
• History of alcohol abuse or illicit drug use within the past 6 months
• Terminally ill or moribund condition with little chance of short-term survival
• Receiving vasopressin or its analogs for treatment of any condition
• Known allergy to any vasopressin antagonist
• Previous participation in a lixivaptan study

Where it is running

• PsyPharma Global — Phoenix, Arizona, United States
• Research Site — Los Angeles, California, United States
• Research Site 1 — Los Angeles, California, United States
• Research Site 1 — Roseville, California, United States
• Research Site — Aurora, Colorado, United States
• The George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Healthcare Clinical Data, Inc — North Miami, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Research Site — Augusta, Georgia, United States
• RTR Medical Group — Savannah, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site 1 — Iowa City, Iowa, United States
• Four Rivers Clinical Research, Inc. — Paducah, Kentucky, United States
• Louisiana Research Associates, Inc. — New Orleans, Louisiana, United States
• Research Site — Belmont, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Research Site — Kansas City, Missouri, United States
• Research Site 1 — Las Vegas, Nevada, United States
• Research Site 1 — Albany, New York, United States
• Erie County Medical Center — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Three Rivers Health and Rehabilitation — Windsor, North Carolina, United States
• Research Site 1 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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