Trial · NCT01938547
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy: Median Time to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | Efficacy: Median time to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart). The reason for initiating clevidipine administration was to keep blood pressure within a pre-specified range during surgery. Time to first achieve SBP target range within first 30 minutes. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. Treatment period: from study drug initiation to termination of infusion (up to 96 hours) was: Phase 1: initial dosing (0 to 1.5 minutes); Phase 2: titration and maintenance phase (\>1.5 minutes up to 96 hours); Phase 3: transition and termination phase where the study drug is ceased, and the patient is transitioned to an alternative IV or oral antihypertensive if required. |
| Primary | Efficacy: Number and Percentage of Participants Achieving the Initial Pre-specified Target SBP Range -- During First 30 Min of Clevidipine Infusion | During the first 30 minutes of clevidipine infusion start (baseline). | Efficacy: Number and percentage of participants achieving the initial pre-specified target SBP range within first 30 minutes of clevidipine infusion. |
| Primary | Efficacy: Total Dose to Attain the Initial Pre-specified Target SBP Range | During the first 30 minutes of clevidipine infusion start (baseline). | Efficacy: Total dose infused to attain the initial pre-specified target SBP range (≥20 mm Hg and ≤ 40 mm Hg apart) within the first 30 min. |
| Primary | Pharmacology: Pharmacodynamic Variable -- Infusion Rate | Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours). | Pharmacodynamic (PD) variable: infusion rate. A target systolic blood pressure (SBP) range was specified for each patient prior to study drug initiation by the Investigator and could not be changed for the first 30 minutes of the treatment period. Adolescent patients received an initial weight-based dose of 0.4 μg/kg/minute, to be maintained for the first 1.5 minutes. |
| Primary | Pharmacology: Clevidipine -- Tmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Tmax: The time it takes for a drug to reach the maximum concentration after administration of a drug. |
| Primary | Pharmacology: Clevidipine -- Cmax | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Cmax: Highest concentration of a drug reached after administration. |
| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve (AUCall) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC all: Area under the curve, represents the total drug exposure integrated over time. |
| Primary | Pharmacology: Clevidipine -- Area Under the Concentration Curve Infinity (AUCinf) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. AUC inf: Area under the curve of the blood concentration from time zero and extrapolated to infinity. |
| Primary | Pharmacology: Clevidipine -- Volume of Distribution (Vd) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. Vd: Volume of distribution is defined as the total amount of drug in the body divided by its concentration in plasma. |
| Primary | Pharmacology: Clevidipine -- Total Clearance (CL) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. CL: Total Clearance is defined as the rate at which a drug is removed from plasma (mg/min) divided by the concentration of that drug in the plasma (mg/mL). |
| Primary | Pharmacology: Clevidipine -- Half-Life (T1/2) | From 30 minutes before start of infusion up to termination of infusion (minimum of 9 hours up to a maximum of 96 hours). | Pharmacology: Pharmacokinetic (PK) variables for clevidipine were established by non-compartmental analysis and non-linear mixed effects modelling (NONMEM). PK results represent those that were obtained during and after the infusion of clevidipine, started at infusion rate of 0.4 µg/kg/min and then titrated according to the study protocol. T1/2: The half-life of a drug is the time it takes for the amount of a drug's active substance in your body to reduce by half. |
| Secondary | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline) | From infusion start (baseline) to 30 minutes post baseline. | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- During First 30 Min of Infusion Start (Baseline). |
| Secondary | Efficacy: Percent Change From Baseline in SBP -- Hourly Measurements -- From 30 Min to 6 Hours of Infusion Start (Baseline) | At each hour from 30 minutes post-clevidipine infusion start (baseline) to 6 hours from baseline. | Efficacy: Percent change from baseline (infusion start) in SBP at each hour after the first 30 minutes of clevidipine infusion up to the cessation of infusion (up to 6 hours from baseline). |
| Secondary | Efficacy: Percent Change in SBP From Baseline at Each Time Point -- From Cessation of Study Drug Infusion up to 12 Hours | During the first 12 hours (measured at each hour) after cessation of clevidipine infusion. | Efficacy: Percent change in SBP from baseline at each time point -- from cessation of study drug infusion and up to 12 hours. |
| Secondary | Efficacy: Number and Percentage of Patients Falling Below the Target Systolic Blood Pressure Range Lower Limit -- During the First 30 Minutes and During the Entire Drug Treatment Period of Clevidipine Infusion | During the first 30 minutes and during the entire drug treatment period (up to a maximum of 96 hours of clevidipine infusion). | Efficacy: Number and percentage of patients falling below the target systolic blood pressure range lower limit -- during the first 30 minutes and during the entire drug treatment period of clevidipine infusion. |
| Secondary | Efficacy: Number and Percentage of Participants in Whom the SBP Was Within Target Range at Each Hour After the First 30 Minutes of Clevidipine Infusion (up to 6 Hours) | From 30 minutes after infusion start (baseline) and up to 6 hours post-clevidipine infusion. | The number and percentage of participants in whom the SBP was within target range at each hour after the first 30 minutes of clevidipine infusion (up to 6 hours). |
| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR) -- During First 30 Min of Infusion | From infusion start (baseline) to 30 minutes post baseline. | Efficacy: Percent change from baseline in heart rate (HR). From infusion start (baseline) to 30 minutes post baseline. |
| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR). | At each hour after 30 minutes post-clevidipine infusion start (baseline) and up to 6 hours. | Efficacy: Percent change from baseline in heart rate (HR) -- From 30 Min to 6 Hours From Baseline. |
| Secondary | Efficacy: Percent Change From Baseline in Heart Rate (HR) -- From Cessation of Study Drug Infusion up to 12 Hours | At each hour after cessation of clevidipine infusion (up to 12 hours). | Efficacy: Percent change from baseline in heart rate. At each hour after cessation of clevidipine infusion (up to 12 hours). |
| Secondary | Efficacy: Number and Percentage of Participants Requiring Rescue Therapy | Minimum of 30 minutes up to a maximum of 96 hours post infusion start (baseline). | Efficacy: Number and percentage of participants who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during the study drug treatment period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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