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OpenTrials
Completed

NCT Number: NCT00379847

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

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.

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Afula, Israel

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 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

Treatment and study plan

conivaptan

Drug

IV

Other names: Vaprisol, YM087

Primary outcomes

  1. Baseline-adjusted change in AUC for serum sodium

    Time frame: 96 Hours

Secondary outcomes

  1. Comparison of safety between patients in each study arm

    Time frame: 96 Hours

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 25, 2006
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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