Clinical trial NCT00478192: Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Official title: A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyponatremia
Keywords: hyponatremia
hypervolemic
euvolemic
edematous
conivaptan
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 50
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: The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia


Eligibility criteria: Inclusion Criteria:

* Euvolemic or hypervolemic (edematous) based on clinical presentation
* Serum sodium between 115 and 130mEq/L at baseline

Exclusion Criteria:

* Clinical presentation of volume depletion or dehydration

Primary outcomes:
measure: Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.
timeFrame: Baseline and 48 hours
Secondary outcomes:
measure: Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment
timeFrame: Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48
measure: Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium
timeFrame: 48 Hours
measure: Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours
timeFrame: 48 Hours
measure: Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours
timeFrame: 48 Hours
measure: Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours
timeFrame: 48 Hours
measure: Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment
timeFrame: Baseline, Hour 12, Hour 24,Hour 36 and Hour 48
measure: Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment
timeFrame: Baseline, Hour 24 and Hour 48
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Hazard
country: United States
state: Kentucky
city: Detroit
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Coimbatore
country: India
city: Indore
country: India
city: Jaipur
country: India
city: Karnal
country: India
city: Visakhapatnam
country: India
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References:
citation: Koren MJ, Hamad A, Klasen S, Abeyratne A, McNutt BE, Kalra S. Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 May 1;68(9):818-27. doi: 10.2146/ajhp100260.