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| Name | Class |
|---|---|
| EKR Therapeutics, Inc | INDUSTRY |
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The purpose of this study is to compare the safety and efficacy of Cardene I.V. to labetalol administered intravenously for the management of hypertension in the emergency department setting.
More than 3 million patients yearly receive an intravenous antihypertensive agent in the US. Despite this large number of critically ill patients treated annually, little research exists in the area of acute severe hypertension, specifically hypertensive emergency, a serious condition that contributes to morbidity and mortality.
Two agents that are commonly used to treat acute hypertensive crisis include labetalol and nicardipine. Cardene may provide benefits in titration and has shown to have lower dosage adjustments compared to labetalol. Nicardipine has also shown a decreased need for additional antihypertensives when compared to labetalol in patients with stroke in a neurological ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | nicardipine intravenous |
|
| 2 | Active Comparator | Labetalol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicardipine intravenous | Drug | nicardipine intravenous 5 mg/hour titrated every 5 minutes by 2.5 mg/hour until target systolic blood pressure range (TSBPR) is reached or maximum dose of 15 mg/hour is achieved.Following achievement of target systolic blood pressure range the infusion rate should be decreased to 3 mg/hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator. | 30 minutes after initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Dose Titrations Within 30 Minutes | Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group | 30 minutes |
| Emergency Department(ED)Time to Disposition Decision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W. Frank Peacock, MD | The Cleveland Clinic | Principal Investigator |
| Joseph Varon, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44122 | United States | ||
| University of Texas Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25141250 | Derived | Varon J, Soto-Ruiz KM, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW, Peacock WF. The management of acute hypertension in patients with renal dysfunction: labetalol or nicardipine? Postgrad Med. 2014 Jul;126(4):124-30. doi: 10.3810/pgm.2014.07.2790. | |
| 23535700 |
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Eligible patients had 2 systolic blood pressures(BP) measures > 180 mmHg at least 10 minutes apart, and no contraindications.Emergency room setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicardipine Dosing Was 5 mg/Hour | nicardipine intravenous |
| FG001 | Bolus Labetalol Began at 20 mg Over 2 Minutes | Labetalol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicardipine Dosing Was 5 mg/Hour | nicardipine intravenous |
| BG001 | Bolus Labetalol Began at 20 mg Over 2 Minutes | Labetalol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator. | Intent to treat cohort. | Posted | Number | percentage of participants | 30 minutes after initiation of therapy |
|
Emergency Room visit
Elevated cardiac markers
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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 | Nicardipine | Nicardipine dosing was 5 mg/hour |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated cardiac biomarkers | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Peacock MD | Cleveland Clinic | (216) 445-4557 | peacocw@ccf.org |
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| ID | Term |
|---|---|
| D000096003 | Hypertensive Crisis |
| D006973 | Hypertension |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009529 | Nicardipine |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Labetalol | Drug | Labetalol: bolus therapy to start at 20 mg intravenous injection over 2 minutes, may repeat 20mg, 40mg or 80mg injections every 10 minutes until target systolic blood pressure range(TSBPR)is reached or a maximum of 300 mg is injected. |
|
Median number of hours from hospital admission until Emergency Department(ED)disposition
| 6 hours |
| Treatment Failure | Treatment failure is defined as admission to the hospital or observation unit for BP management | 6 hours |
| Subjects Requiring the Use of Intravenous Rescue Medications | The percent of subjects requiring the use of intravenous rescue medications | 6 hours |
| Transition Time to Oral Medication | The median transition time (in hours) to oral medication | 6 hours |
| Houston |
| Texas |
| United States |
| Cannon CM, Levy P, Baumann BM, Borczuk P, Chandra A, Cline DM, Diercks DB, Hiestand B, Hsu A, Jois P, Kaminski B, Nowak RM, Schrock JW, Varon J, Peacock WF. Intravenous nicardipine and labetalol use in hypertensive patients with signs or symptoms suggestive of end-organ damage in the emergency department: a subgroup analysis of the CLUE trial. BMJ Open. 2013 Mar 26;3(3):e002338. doi: 10.1136/bmjopen-2012-002338. |
| 21707983 | Derived | Peacock WF, Varon J, Baumann BM, Borczuk P, Cannon CM, Chandra A, Cline DM, Diercks D, Hiestand B, Hsu A, Jois-Bilowich P, Kaminski B, Levy P, Nowak RM, Schrock JW. CLUE: a randomized comparative effectiveness trial of IV nicardipine versus labetalol use in the emergency department. Crit Care. 2011;15(3):R157. doi: 10.1186/cc10289. Epub 2011 Jun 27. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
|
|
|
| Secondary | Average Number of Dose Titrations Within 30 Minutes | Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group | Posted | Mean | Standard Deviation | number of titrations | 30 minutes |
|
|
|
|
| Secondary | Emergency Department(ED)Time to Disposition Decision | Median number of hours from hospital admission until Emergency Department(ED)disposition | these are the correct participant numbers for this secondary analysis | Posted | Median | Inter-Quartile Range | hours | 6 hours |
|
|
|
|
| Secondary | Treatment Failure | Treatment failure is defined as admission to the hospital or observation unit for BP management | these are the correct participant numbers for this secondary analysis | Posted | Number | percentage of participants | 6 hours |
|
|
|
|
| Secondary | Subjects Requiring the Use of Intravenous Rescue Medications | The percent of subjects requiring the use of intravenous rescue medications | Posted | Number | percentage of participants | 6 hours |
|
|
|
|
| Secondary | Transition Time to Oral Medication | The median transition time (in hours) to oral medication | these are the correct participant numbers for this secondary analysis | Posted | Median | Inter-Quartile Range | hours | 6 hours |
|
|
|
|
| 0 |
| 110 |
| 1 |
| 110 |
| EG001 | Labetalol | Bolus Labetalol began at 20 mg over 2 minutes | 0 | 116 | 0 | 116 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |