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

Hyponatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380575
• Other study ID #: 087-CL-027
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2006
• Last updated: April 30, 2014
• Start date: August 2000
• Est. completion date: February 2003

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaIsrael: Ministry of HealthSouth Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• YM087

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals	Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Israel,  South Africa, 

References & Publications (2)

Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. Epub 2008 Jul 1. — View Citation

Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. Epub 2007 Jul 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).