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    Summary
    EudraCT Number:2006-005192-18
    Sponsor's Protocol Code Number:A5351022
    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:2007-01-09
    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 number2006-005192-18
    A.3Full title of the trial
    A 1-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OVERWEIGHT, ORAL AGENT-TREATED SUBJECTS WITH TYPE 2 DIABETES MELLITUS
    A.4.1Sponsor's protocol code numberA5351022
    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 SponsorPfizer 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 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 CP-945,598
    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 686347-12-6
    D.3.9.2Current sponsor codeCP-945,598
    D.3.9.3Other descriptive name1-[8-(2-chlorophenyl)-9-(4- chlorophenyl)-9H-purin-6-yl]-4- (ethylamino)-4-piperidinecarboxamide HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 CP-945,598
    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 686347-12-6
    D.3.9.2Current sponsor codeCP-945,598
    D.3.9.3Other descriptive name1-[8-(2-chlorophenyl)-9-(4- chlorophenyl)-9H-purin-6-yl]-4- (ethylamino)-4-piperidinecarboxamide HCl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    D.8 Placebo: 2
    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
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine in overweight/obese subjects with type 2 diabetes mellitus whether body weight can be made significantly lower by treatment with CP 945,598 compared to treatment with placebo.
    E.2.2Secondary objectives of the trial
    • Determine in overweight/obese subjects with DM type 2 on MET or SU monotherapy whether HbA1c can be significantly lowered by treatment with CP 945,598 compared to placebo;
    • Effect of CP 945,598 at 1 year on:
    • Proportion of subjects who lose 5% and 10% body weight;
    • Proportion of subjects with HbA1c < 6.5;
    • Proportion of subjects with HbA1c < 7.0;
    • Change from BL waist circumference;
    • Change from BL fasting TG and HDL concentrations;
    • Effect of CP-945,598 on Changes in PRO Scales at 1 year:
    • Uncontrolled Eating
    • Power of Food

    Exploratory Objectives:
    • Safety and tolerability of CP-945,598;
    • Effect of CP-945,598 on sevreral parameters not listed above:
    • pharmacokinetics;
    • PK/PD relationship between CP-945,598 and changes in indices
    of glycemic control, body weight;
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-Study Only: Oral Glucose Tolerance Test (OGTT), amendment 3, 31 May 2007

    - Explore the effect of CP-945,598 on fasting and postprandial insulin concentrations determined from OGTT in subset of subjects

    Sub-Study Only: 7-Point Home Glucose Monitoring, amendment 3, 31 May 2007

    - Explore the effect of CP-945,598 on 7-Point Home Glucose Profiles in a subset of subjects
    E.3Principal inclusion criteria
    1. Male and/or female subjects 18-70 years of age, inclusive, with BMI 27-50 kg/m2
    inclusive, and with type 2 diabetes mellitus as defined by the American Diabetes
    Association for at least 4 months.
    2. Subjects on stable oral anti diabetes regimens (no changes in agents or doses for
    at least 4 months) consisting of sulfonylurea (SU - any locally approved sufonyl-
    urea), metformin (Met), thiazolidinedione (TZD - rosiglitazone or pioglitazone),
    sitagliptin, meglitinides (MEG - repaglinide or nateglinide), or alpha-glucosidase
    inhibitors (AGI - acarbose or miglitol). These agents may be used as monotherapy
    or in combinations found in the table in protocol. Each background diabetes
    medication should be taken at maximally allowable doses per prescribing
    information or taken at doses which are adequate for study participation in the
    judgement of the investigator. Note: Doses of background diabetes medication
    may not be changed during the course of the study except in specific
    circumstances (see Section 6.1 for diabetes management details). For combination
    medication, each component of the combined tablet must satisfy the above
    criteria.
    3. Screening HbA1c between 6.5% and 10%, inclusive.
    4. Week 1 fasting plasma glucose NMT 270 mg/dl (15 mmol/L).
    5. Subjects must have documentation of an appropriate ophthalmologic exam
    (including dilated examination of the fundus) by a qualified health care
    professional, during the 12 months prior to randomization.
    6. For women of childbearing potential, a negative serum pregnancy test will be
    required prior to study inclusion. Female subjects must be surgically sterile or be
    postmenopausal or must agree to use effective contraception during the study.
    For the UK only, acceptable methods of contrazeption are found in Section 4.3.2.1.
    For all other countries, the definition of effective contraception will be based on
    the judgement of the Investigator or a designated associate. Oral contraceptive
    use is permitted if used for at least 3 months before starting study medication.
    7. Evidence of a personally signed and dated informed consent document indicating
    that the subject (or a legally acceptable representative) has been informed of all
    pertinent aspects of the trial.
    8. Subjects who are able to comply with scheduled visits, treatment plan (including
    diet and exercise program), home blood glucose monitoring, laboratory tests, and
    other trial procedures.
    E.4Principal exclusion criteria
    1.Women who are pregnant or lactating, or who are actively planning to become
    pregnant.
    2.Subjects with clinically significant abnormalities identified during the screening
    process. Specific exclusions include:
    a.Subjects with blood pressure reading of systolic BP >155 mmHg and/or diastolic
    BP >95 mmHg (confirmed by repeat measurement at the screening visit ) or
    requiring new pharmacologic treatment or change in current treatment according
    to local guidelines for diabetic patients;
    b.Subjects with clinically significant cardiovascular disease, defined as unstable
    coronary heart disease (CHD), cerebrovascular disease (CVD) or peripheral
    vascular disease (PVD) and/or an event/intervention during the past 6 months;
    Note: Clinically stable subjects with a history of CHD, CVD or PVD, provided that the level of exercise proposed in the trial is deemed safe and appropriate for the subject may be included.
    c.Subjects with dyslipidemia requiring new pharmacological treatment or a change in
    current treatment according to local guidelines for diabetic patients;
    d.Subjects with renal disease including:
    •Any history of nephrotic syndrome,
    •Chronic renal failure and/or serum creatinine above the upper limit of normal (ULN)
    for metformin-treated patients or >1.5 times the ULN for patients not treated with
    metformin.
    e.Subjects with abnormal screening TSH values;
    f.Subjects with significant hepatobiliary disease including:
    •History of hepatitis B or C infection and/or,
    •Aspartate aminotransferase or alanine aminotransferase NLT 2 times the ULN.
    g.History of HIV infection or use of antiretroviral agents;
    h.Subjects with any prior history of malignancy except for:
    •Basal cell carcinoma of the skin curatively treated,
    •Other malignancies (regardless of site) that have been cancer-free for 5 years
    prior to screening.
    i.Subjects with gastrointestinal disease, surgery limiting drug absorption or previous
    history of surgical procedure for weight loss;
    j.Clinical laboratory tests outside the pre-specified exclusionary limits;
    k.Subjects with a history of CNS disorder including:
    •A mood disturbance that meets the criteria for a Major Depressive Disorder within
    the last 10 years prior to screening, defined as requiring hospitalization, two or
    more episodes of a major depressive disorder or any previous suicide attempt;
    •Use of antidepressants that are known to increase weight;
    Note: Subjects on a maintenance dose of other permitted antidepressants for a major depressive disorder, stable and in remission for at least 3 months prior to screening, and who plan to continue this treatment during the entire trial may be included.
    •Subjects with a score of NLT 10 or who score positively on the item 9 addressing
    suicidal ideas on the PHQ-9;
    •Subjects with psychotic conditions or on antipsychotic pharmacotherapy;
    •Subjects with seizure disorders who:
    1.Are not controlled by current antiepileptic treatment, and/or
    2.Are taking antiepileptic drugs (AEDs) known to affect weight positively or
    negatively unless these medications have been taken at a stable dose for at
    least 6 months and the subject’s weight has been stable over the same time
    period, and/or
    •That may increase the risk of a drug-drug interaction.
    •Subjects with neurological disorders that are acute, chronic relapsing, progressive
    or have an unpredictable course.
    3.Subjects who use marijuana (determined by medical history).
    4.Subjects who frequently change smoking habits or have stopped smoking within 6
    months prior to screening.
    5.Subjects with known history of alcoholism or drug abuse or dependence within 1
    year prior to screening.
    6.Subjects with a history of anorexia, bulimia nervosa or binge eating disorder as
    per DSM-IV TR.
    7.Use of prescription drugs or over the counter agents/supplements known to alter
    body weight or appetite within 3 months prior to screening.
    8.Systemic therapy with strong CYP3A inhibitors.
    9.Systemic therapy with clinically significant CYP3A inducers or regular consumption
    of grapefruit/grapefruit juice.
    10.Treatment with any anti-diabetic agent within the last 4 months not allowed in
    inclusion criterion # 2.
    11.Treatment with an investigational drug during the 30 days prior to screening.
    12.Participation in any formal weight loss program within 3 months prior to screening.
    13.Fluctuation in body weight >5% within 3 months prior to screening.
    14.Failure to satisfactorily complete at least 5 of the 7-day food intake and
    physical activity records.
    15.Subjects with any other medical condition or laboratory abnormality prior to
    randomization, which in the opinion of the investigator or sponsor could affect
    subject safety, preclude evaluation of response, or render unlikely that the
    subject would complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in body weight from baseline (Day 1) to 1 year
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Reported Outcomes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months4
    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 months4
    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 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 2007-01-09. 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.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 337
    F.4.2.2In the whole clinical trial 900
    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)
    CP-945,598 is not approved for the treatment of adipositas. Other therapies are available (including medical treatment). Therefore CP-945,598 will not be supplied after the end of this trial. During the final visit the investigator will discuss appropriate treatment with the patient.
    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 Decision2007-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-03
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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