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    Summary
    EudraCT Number:2007-005103-18
    Sponsor's Protocol Code Number:NC20971
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-005103-18
    A.3Full title of the trial
    A phase III, double-blind, randomized placebo-controlled study, to evaluate the
    effects of dalcetrapib on cardiovascular (CV) risk in stable CHD patients, with a
    documented recent Acute Coronary Syndrome (ACS).
    A.3.2Name or abbreviated title of the trial where available
    dal-OUTCOMES
    A.4.1Sponsor's protocol code numberNC20971
    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.3.1Product nameDalcetrapib
    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.3.9.1CAS number 211513-37-0
    D.3.9.2Current sponsor codeRO4607381
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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
    Stable CHD patients, with a documented recent Acute Coronary Syndrome (ACS)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10007649
    E.1.2Term Cardiovascular disorder
    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 objective of this trial is to evaluate the potential of dalcetrapib to
    reduce cardiovascular morbidity and mortality in stable CHD patients, with a
    documented recent ACS.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this trial are as listed below:
    • Assessment of the long-term safety profile of dalcetrapib
    • Evaluation of the effect of dalcetrapib on lipid metabolism and markers of
    inflammation and oxidation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients recently hospitalized for ACS (between 4 and 12 weeks after the index event), and whose residual cardiovascular risk may benefit from an increase in HDL-C as assessed by the investigator, will be enrolled in this trial. ACS is defined as the occurrence of at least one of the following events:
    Myocardial Infarction
    - Spontaneous Myocardial Infarction
    • A diagnosis of a qualifying MI event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or CK-MB mass) with at least one determination > the 99th percentile or upper limits of normal for the laboratory. and at least one of the following described below. Symptoms of myocardial ischemia within 48 hours prior to the MI
    • New ECG findings (or presumed new if no prior ECG available) as described below
    • Loss of viable myocardium based on imaging evidence of new or presumed new wall motion or perfusion deficit (eg, echocardiography, left ventriculography during cardiac catheterization radionuclide angiography, single-photon emission tomography, MRI)
    Procedure-Related Myocardial Infarction after PCI
    Patients experiencing a myocardial infarction after a PCI will also be included in this study. A procedure-related MI after PCI is defined as follows:
    Normal biomarkers (eg, CK-MB or troponin I or T) before the procedure and biomarkers after procedure elevated to >3 times the 99th percentile or upper limits of normal for the laboratory.
    Hospitalization for ACS (ECG Abnormalities without Biomarkers):
    A diagnosis of a qualifying ACS event without increases in cardiac biomarkers will require admission to hospital or emergency room (exceeding 23 hrs) with symptoms presumed to be caused by myocardial ischemia with an accelerating tempo in the prior 48 hrs and/or prolonged (at least 20 min) rest chest discomfort and new ECG findings (or presumed new if no prior ECG available) as described below and at least one of the following:
    • 50% stenosis of an epicardial coronary artery;
    • positive exercise or pharmacologic stress indicating reversible ischemia; or
    • presence of pathologic Q-waves on ECG
    Examples of New ECG findings include:
    • New or presumed new ST depression > 0.5mm in 2 contiguous leads or T wave inversion > 1mm in leads with predominant R wave or R/S >1 in 2 contiguous leads.
    • New or presumed new ST elevation at the J point in ≥ 2 contiguous leads with the cut-off points: ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new or presumed new LBBB
    • New tall R wave > 40ms in V1,V2 and R/S ≥ 1 in V1 with concordant positive T-wave in the absence of a conduction defect.
    • New Q waves ≥ 30 ms wide and > 1mm deep in any 2 leads of a contiguous lead grouping or Q wave >20ms or QS complex in leads V2 and V3 (These criteria also apply to silent MI detected during a routine follow-up visit)
    In addition, the following inclusion criteria apply:
    1. Both male and female patients able and willing to give written informed consent.
    2. Age 45 and over at Visit 1
    3. Signed informed consent (approved by Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
    4. Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
    5. Triglycerides < 400 mg/dL (<4.5 mmol/L) at Visit 2
    6. Evidence-based management of LDL-C cholesterol, at a minimum to include medical and dietary treatment to a target level of <100 mg/dl (<2.6 mmol/L) by the time of randomization, and ideally to include medical and dietary treatment to a target level <70 mg/dl (<1.8 mmol/L). Patients with an LDL-C level above >100 mg/dL may be randomized if they cannot reach the target goal of less than 100 mg/dL despite an intensive statin regimen, are on a maximum tolerated dose of statin as determined by the investigator, or are unable to tolerate statins.
    E.4Principal exclusion criteria
    1. Females who are pregnant or breast-feeding
    2. Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using a highly effective contraceptive method (failure rate less than 1% per year) such as implants, injectibles, combined oral contraceptives or hormonal intrauterine devices (IUDs). In addition, a negative serum pregnancy test must be available before starting the run-in period.
    3. Symptomatic (NYHA Class II or greater) congestive heart failure requiring appropriate medical treatment and persisting despite such treatment at the end of the run-in period. Patients with NYHA Class II heart failure symptoms may be included if a measurement of left ventricular function is performed and ejection fraction is shown to be >40%.
    4. Severe anemia defined as hemoglobin ≤10 g/dL at the end of the run-in period.
    5. Index ACS event presumed due to uncontrolled hypertension and/or systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg by the end of the placebo run-in period despite anti-hypertensive therapy
    6. Hemoglobin A1c >10% at Visit 2
    7. Patients with clinically apparent liver disease, eg, jaundice, choleastasis, hepatic synthetic impairment, or active hepatitis
    8. Hepatic transaminase, alkaline phosphatase or total bilirubin levels >1.5 times the ULN at the end of the run-in period
    9. Unexplained creatine phosphokinase levels >3 times the ULN at visit 2
    10. Serum creatinine > 2.2 mg/dL (194.5 µmol/l) at the end of the run-in period
    11. Concomitant treatment with niacin, fibrates, bile acid sequestrants, or rimonabant. Treatment with ezetimibe or fish oil derivatives is permitted.
    12. Concomitant treatment with any drug other than dalcetrapib administered for the purpose of increasing levels of HDL C.
    13. Previous exposure to torcetrapib or any other CETP inhibitor as for example MK-859
    14. History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.
    15. Any clinically significant medical condition that according to the investigator could interfere with the conduct of the study.
    16. Patients whose life expectancy is shorter than duration of the trial
    17. Presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important.
    18. Current alcohol or drug abuse or history thereof within 5 years prior to screening.
    19. Patients exposed to dalcetrapib within the last 12 months before the start of this study and/or have a known or suspected hypersensitivity to excipients of trial medication, including placebo (which contains lactose)
    20. Subjects who have received any 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
    21. Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the time to first occurrence of any
    component of the composite event; as adjudicated by the Clinical Event
    Committee (CEC). Components of the event are:
    • Coronary heart disease death
    • Major coronary events (nonfatal MI, ,hospitalization for ACS [ECG
    abnormalities without biomarkers] and resuscitated cardiac arrest:)
    • Stroke, fatal or non-fatal, of presumed atherothrombotic etiology
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluation of Biomarkers
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA222
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Stable CHD patients with a documented recent Acute Coronary Syndrome
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6700
    F.4.2.2In the whole clinical trial 15600
    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 Decision2008-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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