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Completed

NCT Number: NCT00492037

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

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

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

YM087 oral

Drug

Primary outcomes

  1. Change in serum sodium from Baseline Safety of each dosing regimen

    Time frame: Beginning through end of treatment

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Collaborators

  • Parke-Davis

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2002
First posted
Jun 27, 2007
Registry last updated
May 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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