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

NCT ID NCT00072683

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HYPONATREMIAS are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

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