"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances

In brief

This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.

Key facts

Study ID

NCT00072683

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

205

Starts

2003-04-01

Expected to finish

2005-12-01

Last updated by the study team

2026-07-13

Who can join

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

You may qualify if…

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

You may not qualify if…

• 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
• 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 > 300 mg/dL
• Urinary tract obstruction except benign prostatic hyperplasia (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 arginine vasopressin (AVP) or its analogs for treatment of any condition

Where it is running

• VA Greater Los Angeles Health Care Ctr — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Aurora Denver Cardiology Association — Denver, Colorado, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• University of Florida Gainesville — Gainesville, Florida, United States
• Charlotte Heart Group Research Ctr — Port Charlotte, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• Washington University Ctr for Clinical Studies — St Louis, Missouri, United States
• Mercury Street Medical — Butte, Montana, United States
• Northshore University Hospital — Great Neck, New York, United States
• Study site — New York, New York, United States
• University of North Carolina, Div. of Cardiology — Chapel Hill, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• The Arthur P. Noyes Research Foundation — Norristown, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baptist Clinical Research Ctr — Memphis, Tennessee, United States
• Tennessee Center for Clinical Trials — Tullahoma, Tennessee, United States

Full record on ClinicalTrials.gov

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