Clinical trial NCT00380575: Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Keywords: hyponatremia
hypervolemic
euvolemic
vasopressins
YM087
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-09-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tuscon
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Worchester
country: United States
state: Massachusetts
city: Petoskey
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rolla
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Columbia
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Huntington
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
city: Drummondville
country: Canada
state: Quebec
city: Montreal 2 sites
country: Canada
state: Quebec
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Haifa 2 Sites
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Rechovot
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Amanzimtoti
country: South Africa
city: Bloemfontein
country: South Africa
city: Buff
country: South Africa
city: Durban
country: South Africa
city: East London
country: South Africa
city: Johannesburg
country: South Africa
city: Lyttelton Manor
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References:
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. doi: 10.1159/000106456. Epub 2007 Jul 26.
citation: 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. doi: 10.1111/j.1365-2265.2007.03149.x. Epub 2008 Jul 1.