Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
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ClinicalTrials.gov Identifier: NCT00478192 |
Recruitment Status :
Completed
First Posted : May 24, 2007
Results First Posted : April 21, 2010
Last Update Posted : May 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyponatremia | Drug: Conivaptan Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | April 2007 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Regimen 1 Conivaptan QD
20 mg conivaptan once a day
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Drug: Conivaptan
premix bag
Other Names:
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Experimental: Regimen 2 Conivaptan BID
20 mg conivaptan two times a day
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Drug: Conivaptan
premix bag
Other Names:
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Placebo Comparator: Regimen 3 Placebo |
Drug: Placebo
premix bag |
- Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. [ Time Frame: Baseline and 48 hours ]
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.
- Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment [ Time Frame: Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48 ]
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
- Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium [ Time Frame: 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.
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.
- Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours [ Time Frame: 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.
- 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 [ Time Frame: 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.
- Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours [ Time Frame: 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
- Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment [ Time Frame: Baseline, Hour 12, Hour 24,Hour 36 and Hour 48 ]
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
- Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment [ Time Frame: Baseline, Hour 24 and Hour 48 ]
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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478192
United States, Alabama | |
Huntsville, Alabama, United States, 35801 | |
United States, Arizona | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
Los Angeles, California, United States, 90073 | |
United States, Colorado | |
Denver, Colorado, United States, 80218 | |
United States, Florida | |
Jacksonville, Florida, United States, 32216 | |
Port Charlotte, Florida, United States, 33952 | |
United States, Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46260 | |
United States, Kentucky | |
Hazard, Kentucky, United States, 41701 | |
United States, Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68198 | |
United States, New York | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45267 | |
Fairfield, Ohio, United States, 45014 | |
Toledo, Ohio, United States, 43606 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19102 | |
Philadelphia, Pennsylvania, United States, 19104 | |
Philadelphia, Pennsylvania, United States, 19107 | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, South Carolina | |
Charleston, South Carolina, United States, 29425 | |
Orangeburg, South Carolina, United States, 29118 | |
India | |
Coimbatore, India, 641014 | |
Indore, India, 452014 | |
Jaipur, India, 302013 | |
Karnal, India, 132001 | |
Visakhapatnam, India, 530002 |
Study Director: | Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. |
Publications:
Responsible Party: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00478192 |
Other Study ID Numbers: |
087-CL-088 |
First Posted: | May 24, 2007 Key Record Dates |
Results First Posted: | April 21, 2010 |
Last Update Posted: | May 15, 2014 |
Last Verified: | April 2014 |
hyponatremia hypervolemic euvolemic edematous conivaptan |
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases Conivaptan |
Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |