Trial · NCT00666328
Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
NCT00666328, Phase 3, Completed, The Medicines Company; results first posted 2013-04-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE). Trials, record NCT00666328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00666328
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clevidipine in the Treatment of Patients With Acute Hypertension and Intracerebral Hemorrhage (ACCELERATE)
- NCT number
- NCT00666328
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 37 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- Hypertension, Hemorrhage
- Interventions
- clevidipine
- First posted
- 2008-04-24
- Last updated
- 2014-08-29
- Results first posted
- 2013-04-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine | Within 30 minutes of study drug initiation | The median time, in minutes, was estimated with its two-tailed 95% confidence interval from the time of the initiation of clevidipine infusion until the first observed SBP was achieved in the target range of ≤160 mmHg to ≥140 mmHg within the first 30 minutes of clevidipine treatment. If patients did not reach the blood pressure target range within the first 30 minutes, their data was considered censored at 30 minutes. If another IV and/or oral antihypertensive agent indicated for hypertension was administered less than 30 minutes prior to achieving the endpoint, the data was considered censored at the time when the additional or alternative antihypertensive agent was given. |
| Secondary | Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine | Within 30 minutes of study drug initiation | The percentage of patients who reached SBP of ≤160 mmHg within the first 30 minutes of initiation of clevidipine infusion was summarized. If an additional or alternative IV antihypertensive agent and/or oral antihypertensive agent was administered for hypertension prior to a patient achieving SBP≤160 mmHg during the initial 30-minute treatment period, then the patient was considered to have failed to reach this efficacy endpoint. |
| Secondary | Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Baseline through 30 minutes post initiation of clevidipine infusion | Over the initial 30 minutes of the treatment period, the percent change from baseline (defined as immediately prior to study drug initiation) was summarized descriptively at 1, 2, 3, 4, 5, 6, 7, 10, 15, 20, 25, and 30 minutes after clevidipine initiation. Decreases in SBP from baseline were observed over the course of this time period. |
| Secondary | Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion | Duration of the study drug infusion (up to 96 hours) | Total AUC-SBP captures the magnitude and duration of SBP either above the upper limit of the target SBP range at 160 mm Hg or below the lower limit of 140 mm Hg and normalized per hour for the duration of clevidipine infusion. A larger value for AUC-SBP indicates greater SBP variability outside the target range. |
| Secondary | Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine | From study drug initiation through termination (up to 96 h) | The percent time that SBP was maintained within the SBP target range (≤160 mmHg to ≥140 mmHg) was summarized for each 24-hour period of monotherapy of clevidipine infusion through 96 hours (0 -≤24 h, 24-≤48 h, 48-≤72 h, 72-≤96 h). For purposes of this analysis, SBP data were available from all mITT patients for the overall infusion period and from 0 to ≤24 hours of infusion; however, data was only available for 8 patients from 24 to ≤48 hours, 4 patients from 48 to ≤72 hours and 1 patient from 72 to ≤96 hours due to the variability in infusion durations \>24 hours across patients. |
| Secondary | Mean Dose of Clevidipine During the Treatment Period | Up to 96 hours | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment |
| Secondary | Median Dose of Clevidipine During the Treatment Period | Up to 96 hours | Mean total dose of clevidipine from study drug initiation to the end of clevidipine treatment |
| Secondary | Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine | Up to 96 hours | Additional or alternative antihypertensive agent(s) comprise the use of other antihypertensive agent(s) either with clevidipine (additional) or in place of clevidipine (alternative) for the indication of hypertension from the time of clevidipine initiation to clevidipine termination. For purposes of this analysis, additional or alternative antihypertensive agents did not include oral antihypertensives that were administered in order to transition IV clevidipine-treated patients to oral therapy during the transition period of the study. |
| Secondary | Percent Change in Heart Rate During 30 of Initiation of Clevidipine | From study drug initiation through each specified timepoint | Multiple timepoints were assessed (minutes 1, 2, 3, 4, 5, 10, 15, 20, 30) for analysis of percent change in heart rate during the initial 30 minutes. |
| Secondary | The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion | Within 30 minutes of the initiation of study drug infusion |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine | Within 30 minutes of study drug initiation | Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met. | minutes | MEDIAN |
| SECONDARY | Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine | Within 30 minutes of study drug initiation | Modified Intent To Treat (mITT) population: all participants dosed with clevidipine and in whom all inclusion criteria and none of the exclusion criteria were met. | percent participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Baseline through 30 minutes post initiation of clevidipine infusion | percent change in SBP | MEAN | |
| SECONDARY | Magnitude, Frequency and Duration of Systolic Blood Pressure Excursions (Calculated as Area Under the Curve [AUC]) Outside the Target Range Normalized Per Hour for the Duration of the Clevidipine Monotherapy Infusion | Duration of the study drug infusion (up to 96 hours) | mm Hg × min/hr | MEAN | |
| SECONDARY | Percent Time Blood Pressures Were Maintained Within the Target Range (Systolic Blood Pressure ≤160 mmHg to ≥140 mmHg) Over Each 24 Hour Period During Monotherapy Infusion of Clevidipine | From study drug initiation through termination (up to 96 h) | The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses. | percent time | MEAN |
| SECONDARY | Mean Dose of Clevidipine During the Treatment Period | Up to 96 hours | The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. | milligrams (mg) | MEAN |
| SECONDARY | Median Dose of Clevidipine During the Treatment Period | Up to 96 hours | milligrams (mg) | MEDIAN | |
| SECONDARY | Proportion of Patients Requiring an Additional or Alternative Antihypertensive Agent(s) With or Without Clevidipine | Up to 96 hours | The Modified Intent-to-Treat (mITT) population, defined as all enrolled patients who are eligible for the study (i.e., meet all the inclusion criteria and do not meet any of the exclusion criteria) and treated with clevidipine infusion, population will be the primary population for the efficacy analyses. | participants | NUMBER |
| SECONDARY | Percent Change in Heart Rate During 30 of Initiation of Clevidipine | From study drug initiation through each specified timepoint | The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. Data for 33 of the 35 patients in the Safety population had data for the 30 minute time point used for this analysis. | percent change | MEAN |
| SECONDARY | The Percentage of Patients Whose Systolic Blood Pressure is <90 mmHg Within 30 Minutes of the Initiation of Clevidipine Infusion | Within 30 minutes of the initiation of study drug infusion | The Safety population is defined as all enrolled patients who are dosed with clevidipine. This population serves as the primary population for the safety analyses. | percent participants | NUMBER |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time to Achieve Target SBP Range (≤160 mmHg to ≥140 mmHg) Within 30 Minutes of Initiation of Clevidipine | Clevidipine | 5.5 | 95% Confidence Interval 3 to 10 | minutes | |
| Percentage of Participants Achieving a SBP of ≤160 mmHg Within 30 Minutes of Initiation of Clevidipine | Clevidipine | 97 | 95% Confidence Interval 84.2 to 99.9 | percent participants | |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 1 Min. | -2.2 | Standard Deviation 5.76 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 2 Min. | -4.7 | Standard Deviation 9.43 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 3 Min. | -5.9 | Standard Deviation 8.95 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 4 Min. | -8.5 | Standard Deviation 8.54 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 5 Min. | -9.8 | Standard Deviation 9.15 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 6 Min. | -11.3 | Standard Deviation 10.54 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 7 Min. | -13.9 | Standard Deviation 9.92 | percent change in SBP |
| Percent Change From Baseline in Systolic Blood Pressure During the Initial 30 Minutes of Clevidipine Infusion | Clevidipine | Baseline Through Initial 10 Min. | -14.0 | Standard Deviation 11.52 | percent change in SBP |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clevidipine | 35 | |
| Overall Study | Modified Intent To Treat (mITT) | Clevidipine | 33 | |
| Overall Study | COMPLETED | Clevidipine | 30 | |
| Overall Study | NOT COMPLETED | Clevidipine | 5 |
Source ClinicalTrials.gov
Adverse events26
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 | Hypotension | Vascular disorders | Clevidipine | 3 | 35 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Clevidipine | 2 | 35 | |
| other | Nausea | Gastrointestinal disorders | Clevidipine | 3 | 35 | |
| other | Vomitting | Gastrointestinal disorders | Clevidipine | 2 | 35 | |
| other | Pyrexia | General disorders | Clevidipine | 7 | 35 | |
| other | Blood creatinine increased | Investigations | Clevidipine | 2 | 35 | |
| other | Prothrombin time prolonged | Investigations | Clevidipine | 2 | 35 | |
| other | White blood cell count increased | Investigations | Clevidipine | 2 | 35 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Clevidipine | 2 | 35 | |
| other | Hypertriglyceridaemia | Metabolism and nutrition disorders | Clevidipine | 3 | 35 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clevidipine | ||
| Total, other adverse events | Clevidipine | 27 | 35 |
| Total, serious adverse events | Clevidipine | 9 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT00666328
GET https://conductscience.org/api/trials/v1/NCT00666328/results?page=2