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Can a daily pill restore sodium balance in patients with hyponatremia?

NCT ID NCT00072683

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests whether the drug tolvaptan can safely bring sodium and water levels back to normal in people with low blood sodium (hyponatremia). Participants take a daily tablet or a placebo for a set period. The trial focuses on patients whose hyponatremia is due to excess body water, not dehydration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tolvaptan
What this could lead to
If it works, this could provide a new treatment option to correct low sodium levels and reduce related complications.
What could go wrong
This is a phase 3 trial, but results may not apply to all types of hyponatremia. Tolvaptan can cause side effects like thirst, dry mouth, or rapid sodium correction, which must be monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

205 people

The number who actually took part.

Started

Apr 2003

Finished

Dec 2005

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Hyponatremia in euvolemic or hypervolemic states, defined as serum sodium \<135 mEq/L prior to randomization * Able to give 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 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 * Patients receiving within 7 days of randomization, other medications for treatment of hyponatremia specifically: demeclocycline, lithium carbonate or urea * Patients likely requiring intravenous (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.

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Conditions

The condition(s) this trial relates to.

diabetes insipidus Fibrosis Hyponatremia inappropriate ADH syndrome water intoxication Water-Electrolyte Imbalance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyponatremias Inappropriate adh syndrome Water intoxication Water-electrolyte imbalances

Contacts and locations

Locations

  • Study site

    New York, New York, 10010, United States

  • Aurora Denver Cardiology Association

    Denver, Colorado, 80218, United States

  • Baptist Clinical Research Ctr

    Memphis, Tennessee, 38120, United States

  • Charlotte Heart Group Research Ctr

    Port Charlotte, Florida, 33952, United States

  • Medical College of Georgia

    Augusta, Georgia, 30912, United States

  • Mercury Street Medical

    Butte, Montana, 59701, United States

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417, United States

  • Northshore University Hospital

    Great Neck, New York, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388, United States

  • The Arthur P. Noyes Research Foundation

    Norristown, Pennsylvania, 19401, United States

  • UCLA

    Los Angeles, California, 93552, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Colorado Health Science Center

    Denver, Colorado, 80262, United States

  • University of Florida Gainesville

    Gainesville, Florida, 32610, United States

  • University of Iowa Hospital

    Iowa City, Iowa, 52242, United States

  • University of North Carolina, Div. of Cardiology

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • VA Greater Los Angeles Health Care Ctr

    Los Angeles, California, 90073, United States

  • Washington University Ctr for Clinical Studies

    St Louis, Missouri, 63110, United States