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The clinical study has been terminated based on difficulties to enroll eligible subjects per protocol inclusion and exclusion criteria.
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This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).
Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching loading dose and continuous intravenous infusion for 48 hours |
|
| Conivaptan | Experimental | 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conivaptan | Drug | Premix bag |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) | MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Baseline and 72 Hours |
| Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Baseline, 24 Hours, 48 Hours and 72 Hours |
| Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance |
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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 |
|---|---|---|---|---|---|---|
| Hyderabaad | 500063 | India | ||||
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| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching loading dose and continuous intravenous infusion for 48 hours |
| FG001 | Conivaptan | 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching loading dose and continuous intravenous infusion for 48 hours |
| BG001 | Conivaptan | 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation) | MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline and 72 Hours |
|
Adverse Event collection will begin at the start of study drug infusion and continue through Day 9/ Day of Discharge.
Treatment Emergent Adverse Events are reported and are defined as Adverse Events recorded during the treatment and follow-up periods of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching loading dose and continuous intravenous infusion for 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
The study was terminated because of difficulties in enrolling eligible patients per the protocol inclusion and exclusion criteria.
Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C106389 | conivaptan |
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| placebo | Drug | Premix bag |
|
Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. |
| Baseline, 24 Hours, 48 Hours and Day 9 |
| Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Day 9 |
| Termination of Study Drug Due to an Adverse Event or Intolerability | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | 48.5 Hours |
| Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours |
| Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours |
| Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge) | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9 |
| Total Loop Diuretic Use Through 48 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | 48 Hours |
| Total Urine Output at Hours 6, 12, 24, 48 and 72 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours |
| Karnāl |
| 132001 |
| India |
| New Delhi | 110025 | India |
| New Delhi | 110060 | India |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
| Primary | Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | 24 Hours |
|
|
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline, 24 Hours, 48 Hours and 72 Hours |
|
|
| Secondary | Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance | Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation. MDRD = Modification of Diet in Renal Disease The MDRD equation is a standard calculation for estimated glomerular filtration rate. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline, 24 Hours, 48 Hours and Day 9 |
|
|
| Secondary | Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Day 9 |
|
|
| Secondary | Termination of Study Drug Due to an Adverse Event or Intolerability | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | 48.5 Hours |
|
|
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. Changes in Dyspnea were assessed using the following 7-point Likert scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved. Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours |
|
|
| Secondary | Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment | Dyspnea is defined as the sensation of uncomfortable or difficult breathing. The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity). Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours |
|
|
| Secondary | Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge) | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9 |
|
|
| Secondary | Total Loop Diuretic Use Through 48 Hours | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | 48 Hours |
|
|
| Secondary | Total Urine Output at Hours 6, 12, 24, 48 and 72 | Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination. | Study was terminated - assessment of this Outcome Measure was not performed. | Posted | 6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours |
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| EG001 | Conivaptan | 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours | 1 | 6 | 5 | 6 |
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (9.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
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.