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The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 Conivaptan QD | Experimental | 20 mg conivaptan once a day |
|
| Regimen 2 Conivaptan BID | Experimental | 20 mg conivaptan two times a day |
|
| Regimen 3 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conivaptan | Drug | premix bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Art Wheeler, MD | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21515866 | Background | 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. |
| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
Not provided
One patient in the Placebo arm discontinued prior to dosing and therefore was not included in the Full Analysis Set (FAS) or the Safety Analysis Set (SAF).
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen 1 Conivaptan QD | 20 mg conivaptan once a day |
| FG001 | Regimen 2 Conivaptan BID | 20 mg conivaptan two times a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | premix bag |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tucson |
| Arizona |
| 85723 |
| United States |
| Los Angeles | California | 90073 | United States |
| Denver | Colorado | 80218 | United States |
| Jacksonville | Florida | 32216 | United States |
| Port Charlotte | Florida | 33952 | United States |
| Chicago | Illinois | 60612 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Hazard | Kentucky | 41701 | United States |
| Detroit | Michigan | 48201 | United States |
| Omaha | Nebraska | 68198 | United States |
| The Bronx | New York | 10461 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Fairfield | Ohio | 45014 | United States |
| Toledo | Ohio | 43606 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Charleston | South Carolina | 29425 | United States |
| Orangeburg | South Carolina | 29118 | United States |
| Coimbatore | 641014 | India |
| Indore | 452014 | India |
| Jaipur | 302013 | India |
| Karnāl | 132001 | India |
| Visakhapatnam | 530002 | India |
| FG002 | Regimen 3 Placebo |
| Full Analysis Set / Safety Analysis Set |
|
| End of Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Regimen 1 Conivaptan QD | 20 mg conivaptan once a day |
| BG001 | Regimen 2 Conivaptan BID | 20 mg conivaptan two times a day |
| BG002 | Regimen 3 Placebo | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | mEq/L | Baseline and 48 hours |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | mEq/L | Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Posted | Median | Inter-Quartile Range | Hours | 48 Hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Posted | Number | Patients | 48 Hours |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Posted | Number | Patients | 48 Hours |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data. | Posted | Mean | Standard Deviation | Hour * mEq/L | 48 Hours |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | mL | Baseline, Hour 12, Hour 24,Hour 36 and Hour 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | mL | Baseline, Hour 24 and Hour 48 |
|
Not provided
An Adverse Event was defined as treatment emergent if it occurred after the first dose of study drug through the ninth day after the last dose.
Participants at Risk represent the Safety Analysis Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen 1 Conivaptan QD | 20 mg conivaptan once a day | 6 | 20 | 7 | 20 | ||
| EG001 | Regimen 2 Conivaptan BID | 20 mg conivaptan two times a day | 5 | 20 | 10 | 20 | ||
| EG002 | Regimen 3 Placebo | 2 | 9 | 5 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypocoagulable state | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Ventricular arrthmia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypothyrodism | Endocrine disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bowel sounds abnormal | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Bronchitis chronic | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| Blood creatine phosphokinaise increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Blood presure decreased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Chest X-ray abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Heart sounds abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
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.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director, Medical Affairs | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C106389 | conivaptan |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White |
|
|
| Change from Baseline (N=19; 17; 8) |
|
| ANCOVA |
| 0.019 |
P-Values are not adjusted on the basis of multiple comparrisons |
| 95 |
| No |
| Superiority or Other |
| Statistical Analysis applies to "Change from Baseline". | ANCOVA | <0.001 | P-Values are not adjusted on the basis of multiple comparrisons | 95 | No | Superiority or Other |
| Participants |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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