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

Completed · Phase 3 · Has a placebo group

Conditions studied: Euvolemic Hyponatremia

In brief

The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.

Key facts

Study ID

NCT00876798

Run by

CardioKine Inc.

People needed

206

Starts

2009-06-01

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 (Na+ < 135 mEq/L).
• Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
• In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.

You may not qualify if…

• Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
• Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
• Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
• Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion.
• Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
• Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
• Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia).
• Hyponatremia as a result of any medication that can safely be withdrawn.
• Hyponatremia due to hypothyroidism or adrenal insufficiency.
• Current diagnosis of psychogenic polydipsia.
• Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
• Supine systolic arterial blood pressure of ≤ 90 millimeters of mercury (mmHg).
• Serum creatinine > 3.0 mg/dL (> 265.2 mol/L).
• Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium < 3.5 mEq/L).
• Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin - glycosylated [HbA1c] > 9%).
• ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment.
• History of cerebral vascular accident (CVA) within 30 days prior to screening.
• Severe malnutrition in the Investigator's judgment (e.g., body mass index [BMI] < 17).
• Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis.
• Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive).
• History of chronic drug/medication abuse within the past 6 months or current alcohol abuse.
• 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

• Healthscan Research, LLC — Montgomery, Alabama, United States
• PsyPharma Clinical Research, Inc. — Phoenix, Arizona, United States
• PsyPharma Clinical Research — Phoenix, Arizona, United States
• Southern Arizona VA Health Care System (SAVAHCS) — Tucson, Arizona, United States
• Parkview Rehabilitation and Nursing — Little Rock, Arkansas, United States
• Searcy Medical Center — Searcy, Arkansas, United States
• AV Institute, Inc. — Carson, California, United States
• Royal Care Nursing Home — Fountain Valley, California, United States
• Sarah S. Olelewe, MD, Inc. — Hawthorne, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Olive View - UCLA Medical Center — Sylmar, California, United States
• Senior Care of Colorado, PC — Aurora, Colorado, United States
• Naples Institute for Clinical Research — Bonita Springs, Florida, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Jacksonville Center for CLinical Research — Jacksonville, Florida, United States
• Miami Jewish Home and Hospital for the Aged — Miami, Florida, United States
• Galiz Research — Miami, Florida, United States
• Nephrology Associates of South Miami — Miami, Florida, United States
• Galiz Research — Miami Springs, Florida, United States
• Piedmont Clinical Trials — North Miami, Florida, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Universal Clinical Research & Technology, Inc. — Orlando, Florida, United States
• University Clinical Research & Technology, Inc. — Orlando, Florida, United States
• Coastal Nephrology Associates Reserach Center — Port Charlotte, Florida, United States
• Birmingham Nursing and Rehabilitation East — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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