Trial · NCT00478192
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
NCT00478192, Phase 3, Completed, Cumberland Pharmaceuticals; results first posted 2010-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia. Trials, record NCT00478192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
- NCT number
- NCT00478192
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Cumberland Pharmaceuticals
- Conditions
- Hyponatremia
- Interventions
- Conivaptan, Placebo
- First posted
- 2007-05-24
- Last updated
- 2014-05-15
- Results first posted
- 2010-04-21
- Limitations and caveats
Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | 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. |
| Secondary | Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment | 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 |
| Secondary | Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium | 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. |
| Secondary | Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours | 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. |
| 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 | 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. |
| Secondary | Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours | 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 |
| Secondary | Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment | 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 |
| Secondary | Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Baseline and 48 hours | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | mEq/L | MEAN |
| SECONDARY | Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment | Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48 | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | mEq/L | MEAN |
| SECONDARY | Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium | 48 Hours | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Hours | MEDIAN |
| SECONDARY | Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours | 48 Hours | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Patients | NUMBER |
| 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 | 48 Hours | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Patients | NUMBER |
| SECONDARY | Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours | 48 Hours | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Hour * mEq/L | MEAN |
| SECONDARY | Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment | Baseline, Hour 12, Hour 24,Hour 36 and Hour 48 | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | mL | MEAN |
| SECONDARY | Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment | Baseline, Hour 24 and Hour 48 | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.~The number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles. | mL | MEAN |
Source ClinicalTrials.gov
Results by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 1 Conivaptan QD | Baseline (N= 20; 20; 9) | 126.03 | Standard Deviation 4.017 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 2 Conivaptan BID | Baseline (N= 20; 20; 9) | 126.39 | Standard Deviation 3.581 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 3 Placebo | Baseline (N= 20; 20; 9) | 125.55 | Standard Deviation 3.648 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 1 Conivaptan QD | Hour 48 (N=19; 17; 8) | 130.4 | Standard Deviation 5.21 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 2 Conivaptan BID | Hour 48 (N=19; 17; 8) | 133.4 | Standard Deviation 4.82 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 3 Placebo | Hour 48 (N=19; 17; 8) | 127.6 | Standard Deviation 2.36 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 1 Conivaptan QD | Change from Baseline (N=19; 17; 8) | 4.00 | Standard Deviation 3.80 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 2 Conivaptan BID | Change from Baseline (N=19; 17; 8) | 7.36 | Standard Deviation 4.04 | mEq/L |
| Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation. | Regimen 3 Placebo | Change from Baseline (N=19; 17; 8) | 1.16 | Standard Deviation 2.86 | mEq/L |
| Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment | Regimen 1 Conivaptan QD | Baseline (N=20; 20; 9) | 126.03 | Standard Deviation 4.02 | mEq/L |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen 1 Conivaptan QD | 20 | |
| Overall Study | STARTED | Regimen 2 Conivaptan BID | 20 | |
| Overall Study | STARTED | Regimen 3 Placebo | 10 | |
| Overall Study | Full Analysis Set / Safety Analysis Set | Regimen 1 Conivaptan QD | 20 | |
| Overall Study | Full Analysis Set / Safety Analysis Set | Regimen 2 Conivaptan BID | 20 | |
| Overall Study | Full Analysis Set / Safety Analysis Set | Regimen 3 Placebo | 9 | |
| Overall Study | End of Treatment | Regimen 1 Conivaptan QD | 18 | |
| Overall Study | End of Treatment | Regimen 2 Conivaptan BID | 16 | |
| Overall Study | End of Treatment | Regimen 3 Placebo | 8 | |
| Overall Study | COMPLETED | Regimen 1 Conivaptan QD | 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Regimen 1 Conivaptan QD | 2 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 2 Conivaptan BID | 1 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 3 Placebo | 1 | 9 | |
| other | Hypocoagulable state | Blood and lymphatic system disorders | Regimen 1 Conivaptan QD | 1 | 20 | |
| other | Hypocoagulable state | Blood and lymphatic system disorders | Regimen 2 Conivaptan BID | 0 | 20 | |
| other | Hypocoagulable state | Blood and lymphatic system disorders | Regimen 3 Placebo | 0 | 9 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Regimen 1 Conivaptan QD | 1 | 20 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Regimen 2 Conivaptan BID | 0 | 20 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Regimen 3 Placebo | 0 | 9 | |
| other | Supraventricular tachycardia | Cardiac disorders | Regimen 1 Conivaptan QD | 0 | 20 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen 1 Conivaptan QD | ||
| Total, all-cause mortality | Regimen 2 Conivaptan BID | ||
| Total, all-cause mortality | Regimen 3 Placebo | ||
| Total, other adverse events | Regimen 1 Conivaptan QD | 7 | 20 |
| Total, other adverse events | Regimen 2 Conivaptan BID | 10 | 20 |
| Total, other adverse events | Regimen 3 Placebo | 5 | 9 |
| Total, serious adverse events | Regimen 1 Conivaptan QD | 6 | 20 |
| Total, serious adverse events | Regimen 2 Conivaptan BID | 5 | 20 |
| Total, serious adverse events | Regimen 3 Placebo | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21515866 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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