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

Phase 3CompletedNCT00492037

Cumberland Pharmaceuticals83 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyponatremia

Interventions

YM087 oralDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (29)

Unnamed facility

Brussels, Belgium

Unnamed facility

Liège, Belgium

Outcomes

Primary Outcomes

Change in serum sodium from Baseline Safety of each dosing regimen

Time frame: Beginning through end of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.