Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia

A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral 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

NCT00492037

Enrollment

Registered

2007-06-27

Start date

2000-01-31

Completion date

2002-02-28

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, conivaptan

Brief summary

Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

Interventions

DRUGYM087 oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Serum Sodium 115 to \<130mEq/L * Plasma Osmolarity \<290 mOsmol/kg H2O

Exclusion criteria

* Significant renal insufficiency * Serum sodium increase of ≥8 mEq/L over the baseline day ( Hours 0 to 12)

Design outcomes

Primary

Measure	Time frame
Change in serum sodium from Baseline Safety of each dosing regimen	Beginning through end of treatment

Countries

Belgium, Finland, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Outcome results

None listed

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