Trial · NCT00765648
Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
NCT00765648, Phase 4, Completed, The Cleveland Clinic; results first posted 2014-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department. Trials, record NCT00765648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00765648
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department
- NCT number
- NCT00765648
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 226 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Hypertensive Urgency
- Interventions
- nicardipine intravenous, Labetalol
- First posted
- 2008-10-03
- Last updated
- 2015-01-06
- Results first posted
- 2014-12-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | 30 minutes after initiation of therapy | 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. |
| Secondary | Average Number of Dose Titrations Within 30 Minutes | 30 minutes | Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group |
| Secondary | Emergency Department(ED)Time to Disposition Decision | 6 hours | Median number of hours from hospital admission until Emergency Department(ED)disposition |
| Secondary | Treatment Failure | 6 hours | Treatment failure is defined as admission to the hospital or observation unit for BP management |
| Secondary | Subjects Requiring the Use of Intravenous Rescue Medications | 6 hours | The percent of subjects requiring the use of intravenous rescue medications |
| Secondary | Transition Time to Oral Medication | 6 hours | The median transition time (in hours) to oral medication |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | 30 minutes after initiation of therapy | Intent to treat cohort. | percentage of participants | NUMBER |
| SECONDARY | Average Number of Dose Titrations Within 30 Minutes | 30 minutes | number of titrations | MEAN | |
| SECONDARY | Emergency Department(ED)Time to Disposition Decision | 6 hours | these are the correct participant numbers for this secondary analysis | hours | MEDIAN |
| SECONDARY | Treatment Failure | 6 hours | these are the correct participant numbers for this secondary analysis | percentage of participants | NUMBER |
| SECONDARY | Subjects Requiring the Use of Intravenous Rescue Medications | 6 hours | percentage of participants | NUMBER | |
| SECONDARY | Transition Time to Oral Medication | 6 hours | these are the correct participant numbers for this secondary analysis | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | Nicardipine | 91.7 | percentage of participants | ||
| Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes. | Labetalol | 82.5 | percentage of participants | ||
| Average Number of Dose Titrations Within 30 Minutes | Nicardipine | 2.2 | Standard Deviation 1 | number of titrations | |
| Average Number of Dose Titrations Within 30 Minutes | Labetalol | 1.3 | Standard Deviation 0.97 | number of titrations | |
| Emergency Department(ED)Time to Disposition Decision | Nicardipine | 4.6 | Inter-Quartile Range 3.5 to 6.6 | hours | |
| Emergency Department(ED)Time to Disposition Decision | Labetalol | 4.6 | Inter-Quartile Range 3.1 to 7.6 | hours | |
| Treatment Failure | Nicardipine | 43.1 | percentage of participants | ||
| Treatment Failure | Labetalol | 37.4 | percentage of participants | ||
| Subjects Requiring the Use of Intravenous Rescue Medications | Nicardipine | 15.5 | percentage of participants | ||
| Subjects Requiring the Use of Intravenous Rescue Medications | Labetalol | 22.4 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nicardipine Dosing Was 5 mg/Hour | 110 | |
| Overall Study | STARTED | Bolus Labetalol Began at 20 mg Over 2 Minutes | 116 | |
| Overall Study | COMPLETED | Nicardipine Dosing Was 5 mg/Hour | 109 | |
| Overall Study | COMPLETED | Bolus Labetalol Began at 20 mg Over 2 Minutes | 114 | |
| Overall Study | NOT COMPLETED | Nicardipine Dosing Was 5 mg/Hour | 1 | |
| Overall Study | NOT COMPLETED | Bolus Labetalol Began at 20 mg Over 2 Minutes | 2 |
Source ClinicalTrials.gov
Adverse events2
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 | Elevated cardiac biomarkers | Cardiac disorders | Nicardipine | 1 | 110 | 1 |
| other | Elevated cardiac biomarkers | Cardiac disorders | Labetalol | 0 | 116 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nicardipine | ||
| Total, all-cause mortality | Labetalol | ||
| Total, other adverse events | Nicardipine | 1 | 110 |
| Total, other adverse events | Labetalol | 0 | 116 |
| Total, serious adverse events | Nicardipine | 0 | 110 |
| Total, serious adverse events | Labetalol | 0 | 116 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Nicardipine vs Labetalol: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00765648
GET https://conductscience.org/api/trials/v1/NCT00765648/registered