CompletedPhase 3

An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia

United States251 participantsStarted 2004-02

Plain-language summary

This study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate AVP secretion. The population studied will include patients with euvolemic or hypervolemic hyponatremia.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Serum sodium levels less than or equal 130mEq/L * Euvolemic or Hypervolemic hyponatremia Exclusion Criteria: * Clinical evidence of volume depletion or dehydration * Untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency * Uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

What they're measuring

Baseline-adjusted change in AUC for serum sodium

Timeframe: 96 Hours

Trial details

NCT IDNCT00379847

SponsorCumberland Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-06

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