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    Summary
    EudraCT Number:2006-005084-26
    Sponsor's Protocol Code Number:A5351019
    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:2007-03-28
    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 number2006-005084-26
    A.3Full title of the trial
    A 2-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OBESE SUBJECTS
    A.4.1Sponsor's protocol code numberA5351019
    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
    Co-Primary Objectives
    • Determine the effect of CP-945,598 on
    • Percent change in body weight at year 1
    • Proportion of subjects who lose 5% of body weight at year 1
    E.2.2Secondary objectives of the trial
    • Determine the effect of CP-945,598 on:
    • Percent change in body weight at Year 2;
    • Proportion of subjects who lose 10% body weight at Year 1;
    • Changes in waist circumference at Year 1;
    • Changes in HDL and triglycerides at Year 1.
    • Determine the effect of CP-945,598 on Changes in Patient Reported Outcome
    Scales at 1 year:
    • --Uncontrolled Eating
    • --Power of Food

    Exploratory Objectives
    • Evaluate the safety and tolerability of CP-945,598 in a 2-year outpatient setting,
    • Explore the effect of CP-945,598 on:
    • Waist circumference;
    • Proportion of subjects who lose 5 and 10% body weight;
    • Sun/Artificial light related adverse event monitoring;
    • Pharmacodynamic measurements
    • Prevalence of metabolic syndrome;
    • Patient Reported Outcomes;
    • pharmacokinetics of CP-945,598
    • Explore PK/PD relationships between CP-945,598 exposure and changes in body
    weight
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and/or female subjects between 18 and 70 years of age inclusive.
    2. 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.
    Oral contraceptive use is permitted if used for at least 3 months before starting
    study medication.
    3. Male subjects must be surgically sterile or must use effective contraception during
    the study.
    Note: The definition of effective contraception for both women and men will be based on the judgment of the Investigator or a designated associate.
    4. Body Mass Index (BMI) NLT 30 kg/m2, for subjects without co-morbidities; NLT 27 kg/m2
    for subjects with co-morbidities (treated or untreated hypertension and/or
    treated or untreated dyslipidemia):
    A. Hypertension is defined as:
    a. Systolic BP NLT 140 and/or diastolic BP NLT 90 mm Hg and/or,
    b. On anti-hypertensive medication.
    B. Dyslipidemia is defined as:
    a. LDL-C not at goal according to local guidelines and/or,
    b. Triglycerides NLT 150 mg/dL and/or,
    c. HDL-C < 40 mg/dL and/or,
    d. On any anti-dyslipidemic medication.
    Note: Treated subjects for hypertension and/or dyslipidemia should have been on
    stable therapy for at least 2 months prior to screening.
    5. 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.
    6. Subjects who are willing and able to comply with scheduled visits, treatment plan,
    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 the following:
    a. 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.
    b. Subjects with systolic BP NLT 160 and/or diastolic BP NLT 100 mm Hg or requiring new
    pharmacological treatment or change in current treatment according to local
    guidelines.
    c. Subjects with dyslipidemia requiring new pharmacological treatment or change in
    current treatment according to local guidelines.
    d. Subjects with diabetes or fasting blood glucose concentration NLT 126 mg/dL.
    e. Subjects with renal disease including:
    • Any history of nephrotic syndrome
    • Chronic renal failure and/or serum creatinine > 1.5 times the upper limit of normal
    (ULN).
    f. Subjects with abnormal screening TSH values.
    g. 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.
    h. History of HIV infection or use of anti-retroviral agents.
    i. 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 greater
    than 5 years prior to screening.
    j. Subjects with gastrointestinal disease, surgery limiting drug absorption or previous
    history of surgical procedure for weight loss.
    k. Clinical laboratory tests outside the pre-specified exclusionary limits.
    l. 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 a permitted antidepressant 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,
    2. Are taking antiepileptic drugs (AEDs) known to affect weight positively (eg,
    valproic acid) or negatively (eg, topiramate, zonisamide) 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.
    • Subjects with neurological disorders that are acute, chronic relapsing, progressive
    or have an unpredictable course.
    3. Subjects who frequently change smoking habits or have stopped smoking within 6
    months prior to screening.
    4. Subjects who use marijuana (determined by medical history).
    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. Participation in any formal weight loss program within the 3 months prior to
    screening.
    8. Fluctuation in body weight > 5% within 3 months prior to screening.
    9. Failure to satisfactorily complete at least 5 of the 7-day food intake and/or physical
    activity records.
    10. Use of prescription drugs or over the counter agents/supplements known to alter
    body weight or appetite within 3 months prior to screening.
    11. Systemic therapy with strong CYP3A inhibitors.
    12. Systemic therapy with clinically significant CYP3A inducers or regular consumption
    of grapefruit/grapefruit juice.
    13. Treatment with an investigational drug during the 30 days prior to screening.
    14. 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 end of 1 year and year 2
    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 EEA31
    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 months11
    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 months11
    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 2007-03-28. 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 state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1200
    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 further 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 Decision2007-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-03
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