Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia

Hyponatremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478192
• Other study ID #: 087-CL-088
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2007
• Last updated: April 30, 2014
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hyponatremia

Intervention

Drug:
• Conivaptan
premix bag
• Placebo
premix bag

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Countries where clinical trial is conducted

United States,  India, 

References & Publications (1)

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. Erratum in: Am J Health Syst Pharm. 2011 Aug 1;68(15):1374. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.	Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.; Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.; Change is calculated as Hour 48 - Baseline.	Baseline and 48 hours	No
Secondary	Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment	Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.; Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.; Change is calculated as Actual Data for each time point - Baseline	Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48	No
Secondary	Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium	Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.; The endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported.	48 Hours	No
Secondary	Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours	Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.	48 Hours	No
Secondary	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	Confirmed sodium levels refers to two consecutive increases from baseline in sodium of >6 mEq/L or two consecutive measurements >135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.	48 Hours	No
Secondary	Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours	Each individual subject's change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.; "t"=48 Hours	48 Hours	No
Secondary	Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment	Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.; Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.; Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.; Change is calculated as Actual Data for each time point - Baseline	Baseline, Hour 12, Hour 24,Hour 36 and Hour 48	No
Secondary	Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment	Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.; Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.; Hour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.; Change is calculated as Actual Data for each time point - Baseline	Baseline, Hour 24 and Hour 48	No

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