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

A 4-day, Open-Label, Multicenter Phase 3b Study of IV YM087 in Patients With Euvolemic or Hypervolemic Hyponatremia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00379847

Enrollment

251

Registered

2006-09-25

Start date

2004-02-29

Completion date

2005-06-30

Last updated

2014-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

hyponatremia, hypervolemic, euvolemic, treatment outcomes, YM087

Brief 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.

Interventions

DRUGconivaptan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Baseline-adjusted change in AUC for serum sodium	96 Hours

Secondary

Measure	Time frame
Comparison of safety between patients in each study arm	96 Hours

Countries

Israel, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026