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    Summary
    EudraCT Number:2006-005710-12
    Sponsor's Protocol Code Number:Ep_Li 001_2006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-06-18
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005710-12
    A.3Full title of the trial
    Evaluation of the effect of NICOtinic acid (niacin) on elevated Lipoprotein(a) levels (NICOLa Study)
    A.3.2Name or abbreviated title of the trial where available
    NICOLa
    A.4.1Sponsor's protocol code numberEp_Li 001_2006
    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 SponsorCharité Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Niaspan
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    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.3.8INN - Proposed INNNICOTINIC ACID
    D.3.9.1CAS number 59676
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    Lipoprotein (Lp)(a) has been associated with an increased risk of coronary heart disease, cerebrovascular disease, and peripheral arterial vascular disease. Potential therapies to reduce elevated Lp(a) levels include nicotinic acid (niacin), but there is a lack of randomised controlled studies assessing the effectiveness of these therapies in lowering Lp(a) as a primary endpoint and in reducing cardiovascular events in the long term.
    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 compare the effect of niacin therapy on mean change in Lp(a) levels to placebo.
    E.2.2Secondary objectives of the trial
    - To compare the effect of niacin therapy on mean change in plasma lipids levels to placebo
    - To compare the effect of niacin therapy on mean change in blood glucose levels to placebo.
    - To compare the effect of niacin therapy on health-related quality of life (Short Form (SF)-12, EQ-5D)
    - To compare the effect of niacin therapy on cumulative disease-related costs to placebo.
    - To compare safety and tolerability in patients with niacin therapy and placebo
    - To compare medication adherence with niacin therapy and placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Lp(a) plasma levels > 30 mg/dl as measured twice
    - Male or female subjects, aged 18 – 75 years
    - With and without cardiovascular diseases
    - Triglyceride levels < 400 mg/dl
    - Cholesterol and triglyceride levels not requiring immediate change in medication
    - If concurrent statin therapy, stable doses are required prior and during the study
    - Willingness to follow all study procedures
    - Written informed consent
    E.4Principal exclusion criteria
    - Known hypertriglyceridaemia or fasting triglycerides > 400 mg/dl
    - Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia
    - Documented secondary hypercholesterolaemia of any cause
    - Initiation or dose change of a lipid-modifying drug within the last four weeks
    - Known hypersensitivity to nicotinic acid or any components or their derivatives
    - Concurrent treatment with products containing significant amounts of niacin or nicotinamide
    - Concurrent treatment with an immediate release formulation of nicotinic acid or a nicotinic acid analogue, e.g. supplements
    - Cardiovascular diseases which are contra-indicated
    - Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception
    - History of malignancy within preceding 10 years
    - Use of disallowed concomitant medication
    - History of alcohol or drug abuse, or both
    - Active liver disease or hepatic dysfunction
    - Known uncontrolled or poorly controlled diabetes
    - Persistent uncontrolled or untreated hypertension
    - Unexplained serum creatine phosphokinase (CK) >3 times the ULN in the last 4 weeks before the randomisation visit
    - History of severe myalgia of unknown origin
    - Arterial bleeding
    - Active peptic ulcer
    - Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
    - Active gout symptoms
    - Significant renal insufficiency
    - Planned hospitalizations for diagnostic or surgical procedures within the next 5 months
    - Known infectious disease such as hepatitis or HIV
    - Participation in another investigational drug trial within the four weeks prior to study entry
    - Previous randomisation into this study
    - Subjects with serious or unstable medical or psychological condition
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the reduction of cardiovascular events by niacin in patients with elevated Lp(a) levels.
    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 No
    E.6.5Efficacy No
    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 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 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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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 Decision2007-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-02-28
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