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    Summary
    EudraCT Number:2013-001268-44
    Sponsor's Protocol Code Number:MDCO-CLV-12-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-09-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-001268-44
    A.3Full title of the trial
    Open label study to assess the efficacy, safety and dosing of clevidipine in pediatric patients undergoing surgery.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label study to assess the efficacy, safety and dosing of clevidipine in children undergoing surgery.
    A.3.2Name or abbreviated title of the trial where available
    PIONEER
    A.4.1Sponsor's protocol code numberMDCO-CLV-12-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01938547
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/009/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChiesi USA, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportChiesi USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi USA, Inc.
    B.5.2Functional name of contact pointMary Price
    B.5.3 Address:
    B.5.3.1Street Address1255 Crescent Green Dr. Ste 250
    B.5.3.2Town/ cityCary
    B.5.3.3Post code27518
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1919678-6629
    B.5.6E-mailmary.price@chiesi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cleviprex
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLEVIDIPINE
    D.3.9.1CAS number 166432-28-6
    D.3.9.4EV Substance CodeSUB06655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Blood pressure management in pediatric patients in the perioperative setting. Treatment of hypertensive patients and normotensive patients who require lowering of blood pressure for the procedure.
    E.1.1.1Medical condition in easily understood language
    Blood pressure management in children who are undergoing surgery, immediately before surgery or immediately after surgery.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the dosing, efficacy and safety of an intravenous (IV) infusion of clevidipine for blood pressure (BP) management in pediatric patients in the perioperative setting.
    This will be accomplished by assessment of the median time and dose to attain a prespecified target SBP range during the first 30 minutes of clevidipine infusion, the percentage of patients achieving the pre-specified range during the first 30 minutes of clevidipine infusion, as well as the pharmacokinetic variables established by sparse population methodology and pharmacodynamic variables. Safety will be assessed according to clinical laboratory parameters, adverse events and serious adverse events (SAEs) will be assessed from time of consent through 7 days following termination of the study drug infusion.
    E.2.2Secondary objectives of the trial
    To evaluate additional efficacy, safety and dosing parameters associated with IV infusion of clevidipine in the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be less than 18 years
    2. Written informed consent obtained before initiation of any study-related procedures
    3. The enrolling physician determines that patient will likely require a 15% reduction in BP during the perioperative course
    4. Intra-arterial line available for blood pressure monitoring
    5. Surgical procedure requiring at minimum 1 hour of anesthesia, in which IV antihypertensive therapy to control BP for at least 30 minutes is anticipated
    E.4Principal exclusion criteria
    1. Administration of an IV or oral antihypertensive agent within 2 hours prior to study drug administration
    2. Congenital heart disease described as single ventricle
    3. Evidence of liver failure, severe liver disease, pulmonary disease (e.g. uncontrolled asthma), hyperlipidemia, lipoid nephrosis, lipid dysfunction or acute pancreatitis
    4. Allergy to soya bean oil or egg lecithin
    5. Known to be intolerant to calcium channel blockers
    6. Hemophilia or blood coagulation disorders
    7. Any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
    8. Clinically significant abnormal physical findings at the screening evaluation
    9. Any serious surgical or medical condition which, in the opinion of the investigator, is likely to interfere with study procedures or with the pharmacokinetics or pharmacodynamics of the study drug
    10. Patient is terminally ill (death likely to occur within 48 hours)
    11. Use of Methylphenidate, Calcium Channel blockers, Aripiprazole and other atypical anti psychotics and anti-hypertensives used for BP control within 2 hours prior to study drug initiation
    12. Positive serum or urine pregnancy test for any female of childbearing potential
    13. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
    14. Patients who, for any reason, are deemed by the Investigator to be inappropriate for this study
    15. Patient is a relative of the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study
    16. Patients excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.
    E.5 End points
    E.5.1Primary end point(s)
    1. Median time and dose to attain the initial pre-specified target SBP range (minimum of 20 mmHg and a maximum of 40 mmHg apart) during the first 30 minutes of clevidipine infusion
    2. Percentage of patients achieving the initial pre-specified target SBP range during the first 30 minutes of clevidipine infusion
    3. Pharmacokinetic variables (half-life, area under the curve [AUC], volume of distribution, clearance) established by sparse population methodology
    4. Pharmacodynamic variables (relationship between change from baseline in SBP vs. blood concentration and infusion rate)
    5. Safety of a prolonged infusion of clevidipine (up to 96 hours) assessed according to clinical laboratory parameters, adverse events and serious adverse events (SAEs) will be assessed from time of consent through 7 days following termination of study drug infusion
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Median time obtained, during the first 30 minutes.
    2. During the first 30 minutes.
    3. PK variables sampling times are prior to start of infusion, during infusion, at end of infusion and 12-24 hours post infusion. See protocol for full details.
    4. From 0 to 96 hours
    5. Safety up to 96 hours with AEs and SAEs monitored through 7 days.
    E.5.2Secondary end point(s)
    The percentage of patients who reach the initial pre-specified target SBP range without falling below the lower limit of the pre-specified target range during the first 30 minutes of clevidipine infusion
    The percentage of patients in whom the SBP falls below the lower limit of the pre specified target range at any time during the first 30 minutes and at any time during the entire study drug treatment period
    Percentage change in SBP from baseline at each time point during the first 30 minutes of clevidipine infusion
    Percent change from baseline in SBP at each hour after the first 30 minutes of clevidipine infusion up to the cessation of infusion
    The percentage of patients in whom the SBP is within target range at each hour after the first 30 minute of clevidipine infusion
    Percent change from baseline in heart rate during the first 30 minutes of clevidipine infusion and the rest of the treatment period
    Percentage of patients who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during study drug treatment period, or discontinuation due to adverse events
    Percent change from baseline in SBP over the first 12 hours post study drug termination
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points are assessed during the first 30 minutes of the procedure, with the exception of the patients that require rescue medication (during the first 96 hours) and the percent change in baseline of SBP post study drug termination.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 20
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-09-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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