Trial · NCT00803634
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
NCT00803634, Phase 3, Completed, The Medicines Company; results first posted 2014-08-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO). Trials, record NCT00803634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
- NCT number
- NCT00803634
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- Hypertension, Heart Failure
- Interventions
- Clevidipine, Standard of Care IV antihypertensive
- First posted
- 2008-12-05
- Last updated
- 2014-08-29
- Results first posted
- 2014-08-19
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first. |
| Primary | Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100. |
| Secondary | Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | The percentage of patients reaching this endpoint was calculated within each treatment group using the number of mITT patients reaching the endpoint divided by the number of mITT patients, and multiplied by 100. Two-tailed 95% CIs were computed for these percentages. |
| Secondary | SBP Area Under the Curve (AUC) Outside Prespecified Target Range | Initiation of study drug through end of monotherapy (up to 96 hours) | The magnitude and duration of SBP excursions was calculated as the area under the curve (AUC) for each patient, using the trapezoidal rule, related to time (in minutes) that each patient's SBP was outside the target range. AUC was determined based on data collected from the initiation of study medication through the end of monotherapy treatment up to 96 hours, normalized per hour, and expressed as mmHg × minute/hour. |
| Secondary | Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the first 30 minutes was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages. |
| Secondary | Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study | Initiation through termination of study drug (up to 96 hours) | The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the entire study drug treatment period (up to 96 hours) was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages. |
| Secondary | Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point | Baseline (immediately prior to study drug administration) through 1 hour after study drug termination | A validated visual analog scale (VAS) with a horizontal ruler showing increments from 0 to 100 mm with 0 = Best and 100 = Worst was used. The test was asked from the patient's perspective and had to be administered with patient sitting. Relative change in VAS from baseline is the value at each time point minus the baseline value. Relative change from baseline was summarized descriptively (with associated two-tailed 95% CIs of the mean values) at 15, 30 and 45 minutes and at 1, 2, 3 hours and 12 hours, and 1 hour post termination of study drug treatment. |
| Secondary | Time to Use Other IV Antihypertensives During the Study Drug Administration | Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours | The length of time to use other IV antihypertensive agents was defined as the duration in hours from the initiation of study drug through the time when any other concomitant IV antihypertensive agent was administered, thus, representing the time period without use of any other concomitant IV antihypertensive agent. Median time to use other IV antihypertensive agents was obtained using Kaplan-Meier method. If a patient did not receive any concomitant IV antihypertensive during the 96-hour treatment period, this patient was considered censored at 96 hours. If study drug was stopped less than 96 hours and the patient has no concomitant IV antihypertensive agent, the patient was considered censored when study drug was stopped. |
| Secondary | Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment | Initiation through termination of study drug (up to 96 hours) | The percentage of patients who received any alternative IV antihypertensive drug at any time during the study drug treatment period (up to 96 hours) was calculated using mITT patients within each treatment group. |
| Secondary | Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours) | Initiation through termination of study drug (up to 96 hours) | The percent of patients with at least one episode of SBP \<90 mm Hg was calculated as the number of mITT patients who had at least one episode of SBP\<90 mm Hg during study drug administration up to 96 hours divided by mITT patients, and multiplied by 100 for each treatment group. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Minutes | MEDIAN |
| SECONDARY | Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Percentage of patients | NUMBER |
| SECONDARY | SBP Area Under the Curve (AUC) Outside Prespecified Target Range | Initiation of study drug through end of monotherapy (up to 96 hours) | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | mm Hg x min/h | MEAN |
| SECONDARY | Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes | Initiation of study drug through the initial 30-minutes | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Percentage of patients | NUMBER |
| SECONDARY | Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study | Initiation through termination of study drug (up to 96 hours) | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Percentage of patients | NUMBER |
| SECONDARY | Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point | Baseline (immediately prior to study drug administration) through 1 hour after study drug termination | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | millimeters (mm) | MEAN |
| SECONDARY | Time to Use Other IV Antihypertensives During the Study Drug Administration | Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Hours | MEDIAN |
| SECONDARY | Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment | Initiation through termination of study drug (up to 96 hours) | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours) | Initiation through termination of study drug (up to 96 hours) | Safety population: All randomized and eligible patients who were dosed with study drug. | Percentage of patients | NUMBER |
| SECONDARY | Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours | Initiation through termination of study drug (up to 96 hours) | mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF | Patients | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes | Clevidipine | 15.0 | 95% Confidence Interval 15.0 to 21.0 | Minutes | |
| Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes | Standard of Care | NA | 95% Confidence Interval NA to NA | Minutes | |
| Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes | Clevidipine | 45.5 | 95% Confidence Interval 30.7 to 60.2 | Percentage of patients | |
| Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes | SOC IV Therapy | 51.2 | 95% Confidence Interval 35.9 to 66.5 | Percentage of patients | |
| SBP Area Under the Curve (AUC) Outside Prespecified Target Range | Clevidipine | 494.96 | Standard Deviation 428.554 | mm Hg x min/h | |
| SBP Area Under the Curve (AUC) Outside Prespecified Target Range | Standard of Care | 966.15 | Standard Deviation 860.278 | mm Hg x min/h | |
| Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes | Clevidipine | 34.1 | 95% Confidence Interval 20.5 to 49.9 | Percentage of patients | |
| Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes | Standard of Care | 2.4 | 95% Confidence Interval 0.1 to 12.9 | Percentage of patients | |
| Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study | Clevidipine | 68.2 | 95% Confidence Interval 52.4 to 81.4 | Percentage of patients | |
| Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study | Standard of Care | 70.7 | 95% Confidence Interval 54.5 to 83.9 | Percentage of patients |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clevidipine | 51 | |
| Overall Study | STARTED | Standard of Care | 53 | |
| Overall Study | mITT (Dosed & Have Confirmed AHF) | Clevidipine | 44 | |
| Overall Study | mITT (Dosed & Have Confirmed AHF) | Standard of Care | 41 | |
| Overall Study | COMPLETED | Clevidipine | 45 | |
| Overall Study | COMPLETED | Standard of Care | 48 | |
| Overall Study | NOT COMPLETED | Clevidipine | 6 | |
| Overall Study | NOT COMPLETED | Standard of Care | 5 |
Source ClinicalTrials.gov
Adverse events58
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 | Nausea | Gastrointestinal disorders | Clevidipine | 6 | 51 | |
| other | Nausea | Gastrointestinal disorders | Standard of Care | 6 | 53 | |
| other | Headache | Nervous system disorders | Clevidipine | 11 | 51 | |
| other | Headache | Nervous system disorders | Standard of Care | 13 | 53 | |
| other | Insomnia | Psychiatric disorders | Clevidipine | 3 | 51 | |
| other | Insomnia | Psychiatric disorders | Standard of Care | 0 | 53 | |
| serious | Acute coronary syndrome | Cardiac disorders | Clevidipine | 1 | 51 | 1 |
| serious | Acute coronary syndrome | Cardiac disorders | Standard of Care | 0 | 53 | 0 |
| serious | Angina pectoris | Cardiac disorders | Clevidipine | 1 | 51 | 1 |
| serious | Angina pectoris | Cardiac disorders | Standard of Care | 0 | 53 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clevidipine | ||
| Total, all-cause mortality | Standard of Care | ||
| Total, other adverse events | Clevidipine | 20 | 51 |
| Total, other adverse events | Standard of Care | 19 | 53 |
| Total, serious adverse events | Clevidipine | 12 | 51 |
| Total, serious adverse events | Standard of Care | 10 | 53 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clevidipine vs Standard of Care: 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/NCT00803634
GET https://conductscience.org/api/trials/v1/NCT00803634/results?page=2