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    Summary
    EudraCT Number:2007-002017-39
    Sponsor's Protocol Code Number:067
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002017-39
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate

    the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin

    Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or

    Mixed Dyslipidemia.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number067
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorMERCK SHARP DOHME
    B.1.3.4CountryItaly
    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 nameNiacin/Laropiprant
    D.3.2Product code MK524A
    D.3.4Pharmaceutical form 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 codeMK524A
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameSimvastatin
    D.3.4Pharmaceutical form 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 codeMK524A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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 Primary hypercholesterolemia or

    Mixed Dyslipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level SOC
    E.1.2Classification code 10047065
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective: To evaluate the LDL-C lowering efficacy of the addition of ER

    niacin/laropiprant (1 to 2 g) to simvastatin or atorvastatin (pooled across statin and doses)

    compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with

    primary hypercholesterolemia or mixed dyslipidemia who are not at their NCEP ATP III

    LDL-C goal.
    E.2.2Secondary objectives of the trial
    In patients with primary hypercholesterolemia or mixed dyslipidemia who

    are not at their target LDL-C goal, to assess:

    Percent change in HDL-C

    Percent change in Triglycerides (TG)

    Percent change in TC/HDL-C ratio

    Percent change in LDL-C/HDL-C ratio

    Percent change in Apo B

    Percent change in Apo A-I

    Safety and tolerability

    After 12 weeks of treatment with ER niacin/laropiprant (1 to 2 g) plus simvastatin or

    atorvastatin (pooled across statin doses) compared to doubling the baseline simvastatin or

    atorvastatin pooled doses.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patient is male or female, between 18 to 80 years of age on day of signing informed

    consent.

    2. A female patient who is of reproductive potential agrees to remain abstinent or use (or

    have their partner use) 2 acceptable methods of birth control for the duration of the

    study. An acceptable method of birth control is defined as: intrauterine device (IUD),

    diaphragm with spermicide, contraceptive sponge, condom, vasectomy.

    NOTE: Female patients who have reached menopause*, undergone hysterectomy,

    bilateral oophorectomy, or bilateral tubal ligation are eligible without the use of

    contraceptives.

    Patient needs to meet one of the following:

    is on a stable dose of simvastatin (10 to 20 mg) or atorvastatin (10 mg) for at least

    6 weeks prior to Visit 1 (Week -2) OR

    is on any dose of lovastatin, pravastatin, or fluvastatin at screening visit (Week -6)

    OR

    is naïve to all lipid-lowering therapy for at least 3 month prior to screening visit

    (Week -6).

    4. Naïve patients (not on any lipid lowering therapy 3 months prior to screening visit)

    should meet one of the following at the screening visit to enter the study:

    High risk naïve patient (CHD/CHD risk equivalent including diabetes) has an

    LDL-C &#8805;140 mg/dL and < 190 mg/dL (3.6 and 5.0 mmol/L).

    Multiple risk (&#8805;2 RF) naïve patient has an LDL-C &#8805;180 mg/dL and < 240 mg/dL

    (4.7 and 6.2 mmol/L).

    Low risk (0 to 1 RF) naïve patient has an LDL-C &#8805;220 mg/dL (5.7 mmol/L).

    5. Patient with diabetes mellitus must have a confirmed diagnosis and been on a stable

    dose of antidiabetic pharmacotherapy for 3 months prior to Visit 1.

    6. All patients must meet one of the following criteria (based on NCEP ATP III

    Guidelines) at Visit 1 (see Appendix 6.5 to determine patient risk category):

    High Risk

    Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C

    >100 mg/dL and &#8804;130 mg/dL (2.7 mmol/L and 3.4 mmol/L).

    0524A_067-00_ProtCore VERSION 7.1 APPROVED 09-Apr-2007

    Non-U.S. IND, Ex-U.S. Study Restricted Confidential – Limited Access

    Multiple Risk

    Patient has multiple risk factors (&#8805;2 RF) with an LDL-C >130 mg/dL and

    &#8804;160 mg/dL (3.4 mmol/L and 4.1 mmol/L).

    Low Risk

    Patient is low risk (0 to 1 RF) with an LDL-C >160 mg/dL and &#8804;190 mg/dL

    (4.1 mmol/L and 5.0 mmol/L).
    E.4Principal exclusion criteria
    0524A_067-00_ProtCore VERSION 7.1 APPROVED 09-Apr-2007

    Non-U.S. IND, Ex-U.S. Study Restricted Confidential – Limited Access

    Patient is pregnant, breast-feeding, or expecting to conceive during the study

    including the 14-day poststudy follow-up.

    2. Patient has a history of malignancy &#8804;5 years prior to signing informed consent, except

    for adequately treated basal cell or squamous cell skin cancer or in situ cervical

    cancer.

    Note: Patients with a history of malignancy &#8804;5 years may be allowed in the study if,

    in the opinion of the investigator and Sponsor, they are highly unlikely to relapse

    during the duration of the study.

    3. Female patient is expecting to donate eggs during the study, including 14-day follow-up.

    4. Patient has a history or current evidence of any condition, therapy, or lab abnormality

    that might confound the results of the study, interfere with the patient’s participation

    for the full duration of the study, or is not in the best interest of the patient to

    participate.

    5. Patient is unlikely to adhere to the study procedures, keep appointments, or is

    planning to relocate during the study.

    6. Patient is currently participating in or has previously participated in a study with:

    an investigational compound within 30 days of Visit 1.

    an investigational lipid-modifying compound within 6 weeks of Visit 1 (an

    investigational fibrate within 8 weeks).

    Product: MK-0524A 8

    Protocol/Amendment No.: 067-00

    7. Patient has taken torcetrapib alone or in combination and the last dose was within

    1 year of Visit 1.

    Note: To participate in the study, patients who previously participated in a torcetrapib

    trial must provide documentation that he/she did not receive torcetrapib or that the

    last dose of torcetrapib was greater than 1 year of Visit 1.

    8. Patient has donated and/or received blood as follows:

    donated blood products or has had phlebotomy of >300 mL within 8 weeks prior

    to signing informed consent.

    intends to give or receive blood products during the study.

    intends to donate more than 250 mL of blood products within 8 weeks following

    the last study visit.

    9. Patient has the following exclusionary laboratory values at Visit 1 (see Table 3-2 for

    retest guidelines).

    Creatinine >2.0 mg/dL (177 micromol/L)

    ALT (SGPT) >1.5 x ULN

    AST (SGOT) >1.5 x ULN

    CK >2 x ULN

    10. Patient with Type 1 or Type 2 diabetes mellitus and:

    is poorly controlled (HbA1C at Screening >8.5%)

    is newly diagnosed (within 3 months of Visit 1)

    has recently experienced repeated hypoglycemia or unstable glycemic control

    is taking new or recently adjusted anti-diabetic pharmacotherapy (with the exception

    of ±10 units of insulin) within 3 months of Visit 1.

    11. Patient is, at the time of signing informed consent, a user of recreational or illicit

    drugs or has had a recent history (within the last year) of drug or alcohol abuse.

    12. Patient currently engages, or during the study plans to engage, in vigorous exercise or

    an aggressive diet regimen.

    13. Patient has <80% compliance with dosing during the statin run-in period and in the

    opinion of the investigator, compliance will not improve following proper counsel

    during the active study dosing period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change from baseline in LDL-C at Week 12.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) 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) Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Information not present in EudraCT
    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 2007-07-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 621
    F.4.2.2In the whole clinical trial 1250
    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 Decision2007-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-10
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