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NCT00379847 Clinical Trial

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

Hyponatremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00379847
Other study ID # 087-CL-080
Secondary ID
Status Completed
Phase Phase 3
First received September 21, 2006
Last updated April 30, 2014
Start date February 2004
Est. completion date June 2005

Study information
Verified date April 2014
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIsrael: Israeli Health Ministry Pharmaceutical AdministrationSouth Africa: Medicines Control 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 251
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• conivaptan
IV

Locations
Country Name City State
Israel 2 Sites Haifa
Israel 2 Sites Jerusalem
Israel 2 Sites Safed
South Africa 2 Sites Durban
South Africa 4 Sites Johannesburg

Sponsors (1)
Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  Israel,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline-adjusted change in AUC for serum sodium 96 Hours No
Secondary Comparison of safety between patients in each study arm 96 Hours No
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