Clinical trial NCT00435591: A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Official title: A Phase 4, Randomized, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyponatremia
Euvolemia
Hypervolemia
Keywords: Hyponatremia
Euvolemia
Hypervolemia
Conivaptan
Vaprisol®
YM087
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 121
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 will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia


Eligibility criteria: Inclusion Criteria:

* Subject has a serum sodium value between 115 and 133 mEq/L
* Subject is euvolemic or hypervolemic

Exclusion Criteria:

* Clinical evidence of volume depletion or dehydration
* Uncontrolled brady- or tachyarrhythmias requiring emergent pacemaker placement or treatment

Primary outcomes:
measure: Number and Severity of Infusion Site Reactions (ISRs) Using a Modified ISR Reporting Scale for Phlebitis and Infiltration in Patients Treated With Dose Regimen 1 and Dose Regimen 2
timeFrame: 48 hours
Secondary outcomes:
measure: Change From Baseline in Serum Sodium at Each Time Point Over the Duration of the Treatment Period and 7-day Post Treatment Period
timeFrame: Baseline at 4, 6, 10, 16, 24, 30, 40, 48.5 hours and 7 days post-treatment
measure: Baseline Adjusted Area Under the Concentration - Time Curve (AUC) in Serum Sodium Over the Duration of the First 24.5 Hours, the First 48.5 Hours, and the First 96.5 Hours
timeFrame: 24.5 hours, 48.5 hours and 96.5 hours
measure: Time From the First Dose of Study Drug to a Confirmed > 4 mEq/L Increase From Baseline in Serum Sodium During the 48.5 Hour Treatment Period
timeFrame: 48.5 hours
measure: Number of Patients With Confirmed Serum Sodium Level Exceeding 4 mEq/L Increase From Baseline Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours
timeFrame: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours
measure: Number of Patients With Confirmed Serum Sodium Level Exceeding 6 mEq/L Increase From Baseline or Confirmed Normal Serum Sodium Level Exceeding 135 mEq/L Over the Duration 0-24.5 Hours, 0-48.5 Hours, and 0-96.5 Hours
timeFrame: 0-24.5 hours, 0-48.5 hours and 0-96.5 hours
Other outcomes:
Locations:
city: Charleston
country: United States
state: South Carolina
city: Bangalore
country: India
city: Bangalore
country: India
city: Bhopal
country: India
city: Hyderabaad
country: India
city: Karnal
country: India
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Jerusalem
country: Israel
city: Rechovot
country: Israel
city: Safed
country: Israel
city: Tel Hashomer
country: Israel
city: Tel-Aviv
country: Israel
city: Zerifin
country: Israel
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References:
citation: Kalra S, Efrati S, Arthur JM, Oliven A, Velez JC, McNutt BE, Klasen S, Abeyratne A. Effect of loading dose and formulation on safety and efficacy of conivaptan in treatment of euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 Apr 1;68(7):590-8. doi: 10.2146/ajhp100243.