Can a pill restore sodium balance in patients with hyponatremia?
NCT ID NCT00201994
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This phase 3 trial investigates whether the drug tolvaptan can safely and effectively correct low sodium levels in patients with hyponatremia, a condition where the body's sodium-water balance is off. The study enrolls adults with mild to moderate hyponatremia who are either euvolemic or hypervolemic (normal or excess fluid volume). Participants receive either tolvaptan tablets or a placebo, and researchers track changes in blood sodium and any clinical benefits.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Tolvaptan (also known as Samsca)
- What this could lead to
- If successful, tolvaptan could offer a safe, effective way to correct low sodium levels in patients with hyponatremia, potentially reducing hospital stays and 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, and, rarely, liver injury, so its use requires careful monitoring.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
-
Universitatskilinikum Carl
Gustav Carus, Dresden, D-01307, Germany
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