Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

A 4-Day, Double-Blind, Placebo-Controlled, Multicenter Study of IV YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380575

Enrollment

Registered

2006-09-26

Start date

2000-08-31

Completion date

2003-02-28

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, vasopressins, 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

DRUGYM087

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Serum sodium levels 115 to \< 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
The primary efficacy outcome will be change from baseline in serum sodium over the duration of treatment. The primary safety outcome will be safety parameters (e.g., adverse events, vital signs, EGG, laboratory measurements).	—

Countries

Canada, Israel, South Africa, United States

Outcome results

None listed

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