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    Summary
    EudraCT Number:2007-003406-10
    Sponsor's Protocol Code Number:BC21144
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-23
    Trial results View 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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2007-003406-10
    A.3Full title of the trial
    A Phase IIb, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Artery, 24 hour Ambulatory Blood Pressure, Lipids, Lipoproteins and Markers Vascular Inflammation, Oxidation and CV risk in Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberBC21144
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF.Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.2Product code RO4607381/F51
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeRO4607381
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number300
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10013317
    E.1.2Term Lipid metabolism disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective of this study is to evaluate the effect of RO4607381 on endothelial function as measured by flow mediated dilatation (FMD) of the brachial artery in patients with CHD or CHD risk equivalents at 12 weeks.
    The primary safety objective of this study is to evaluate the effect of RO4607381 on blood pressure as measured by 24 hour ambulatory blood pressure monitoring (ABPM) at 4 weeks.
    E.2.2Secondary objectives of the trial
    Secondary efficacy and safety Objectives
    The secondary objectives of this study are:
    • To evaluate the effect of RO4607381 on endothelial function as measured by flow mediated dilatation (FMD) of the brachial artery in patients with CHD or CHD risk equivalents at 36 weeks
    • To evaluate the effect of RO4607381 on blood pressure as measured by 24 hour ambulatory blood pressure monitoring (ABPM) at 12 and 26 weeks
    • To explore the effect of RO4607381 on biomarkers of inflammation, oxidation and CV risk (hsCRP, IL6, sP Selectin, sE-Selectin, sICAM, sVCAM, PLA2, MMP-3, MMP-9, Adiponectin, MPO, TPA, PAI-1)
    • To explore the effect of RO4607381 on clinical and laboratory parameters including blood lipid, lipoprotein and apolipoprotein levels, CETP mass and activity, and insulin sensitivity
    • To evaluate the safety profile of RO4607381
    • To assess the effect of RO4607381 on clinical outcomes as part of an outcome analysis across the entire phase program
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Roche Sample Repository Research Project in association with protocol BC21144. To obtain a single blood sample from consenting patients enrolled in associated study BC21144 for pharmacogenetic and genetic research analysis.

    Protocol Number RSR BC21144RG, Protocol Version: A, 23-Aug-2007
    E.3Principal inclusion criteria
    •Both male and female patients able and willing to provide written informed consent
    •Age 18-75 years (inclusive) at visit 1
    •Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
    •Patients with CHD or CHD risk equivalent based on NCEP ATPIII, eg. atherosclerosis, diabetes or >20% 10 year risk of CHD events
    •HDL-C <50 mg/dL (<1.3 mmol/L) at visit 1
    •Triglycerides level ≤400 mg/dL (<4.5 mmol/L) at visit 1
    •Appropriately treated with statin and/or other LDL lowering drug to a stable accepted LDL level (<100 mg/dL [<2.6 mmol/L] unless taking maximimum tolerated doses of therapy) based on their medical condition
    E.4Principal exclusion criteria
    •Females who are pregnant or breast feeding
    •Women of child bearing potential (women who are not surgically sterile or post-menopausal defined as amenorrhea for > 12 months or amenorrhea for 6 – 12 months and FSH ≥ 45U/L)
    •Concomitant treatment with niacin, fibrates, bile acid sequestrants, rimonabant or CETP therapy. Treatment with ezetimibe and fish oil derivatives will be permitted.
    •Concomitant treatment with any drug other than RO4607381 administered for the purpose of increasing levels of HDL C.
    •Patients with clinically apparent liver disease, eg, jaundice, choleastasis, hepatic synthetic impairment, or active hepatitis
    •Hepatic transaminase, alkaline phosphatase or total bilirubin levels >1.5 times the ULN at Visit 1
    •Unexplained creatine phosphokinase levels >3 times the ULN at visit 1
    •Uncontrolled blood pressure: Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening or any other pre-randomization visit
    •Serum creatinine > 2.2 mg/dL at Visit 1.
    •Recent (within 3 months before Visit 1) clinically significant coronary events, including unstable angina, myocardial infarction, angioplasty, or coronary artery bypass graft.
    •Recent (within 3 months before Visit 1) transient ischemic attacks or cerebrovascular accident
    •Poorly controlled diabetes mellitus (HbA1c >10%) due to inability to comply with recommended diabetes management
    •Severe anemia defined as hemoglobin (Hb)< 10g/dL
    •Patients with homozygous familial hypercholesterolemia
    •Current or history of drug or alcohol abuse within 5 years of Visit 1
    •History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to Visit 1
    •Any clinically significant medical condition that could interfere with the conduct of the study
    •Presence of any abnormality on a laboratory evaluation performed prior to randomization that is considered by the investigator to be clinically important.
    •History of receiving R04607381 in a clinical trial in the previous 12 months
    •Subjects previously exposed to torcetrapib
    •Use of any investigational drug within 1 month before Visit 1
    •Subjects who have received an investigational drug or device within 1 month of visit 1, or who expect to participate in any other investigational drug or device study during the conduct of this trial
    •Inability or unwillingness to comply with the protocol requirements, or deemed by the investigator to be unfit for the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: change from baseline in %FMD as measured in the right brachial artery 5 to 10 cm proximal to the antecubital fossa with a high resolution ultrasound probe after 12 weeks of treatment.

    Primary Safety Endpoint: change from baseline in mean blood pressure at 4 weeks as measured by 24 hour ambulatory blood pressure monitoring.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker Research
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the date of the last patient visit of the last patient to complete the study, or the date at which the last data point, which is required for statistical analysis (i.e. key safety and efficacy results for decision making), is received, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 450
    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)
    NA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-06
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