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    Summary
    EudraCT Number:2010-020427-43
    Sponsor's Protocol Code Number:B0401011
    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:2010-08-06
    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 number2010-020427-43
    A.3Full title of the trial
    A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF 04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE ON STABLE DONEPEZIL THERAPY
    A.4.1Sponsor's protocol code numberB0401011
    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.235 East 42nd Street, New York, NY 10017
    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.3.1Product namePF-04447943
    D.3.2Product code PF-04447943
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codePF-04447943
    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.3.1Product namePF-04447943
    D.3.2Product code PF-04447943
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codePF-04447943
    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 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
    Alzheimer's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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 Protocol is to assess the efficacy of PF 04447943, relative to placebo, on a performance based measure of cognition in subjects with mild to moderate AD who are on stable donepezil therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    1. To evaluate the effects of PF 04447943 on other clinically relevant measures including behavior, and clinician rated global change;
    2. To evaluate the safety and tolerability of PF 04447943, relative to placebo, in subjects with mild to moderate AD who are on stable donepezil therapy;
    3. To evaluate the pharmacokinetics of PF 04447943 in subjects with mild to moderate AD who are on stable donepezil therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Age range: 55-90 years of age inclusive.
    2. Men and women.
    3. Women must be of non childbearing potential defined as either surgically sterile (both ovaries removed or hysterectomy) or post menopausal for at least 2 years
    4. Male subjects must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 28 days after dosing. The definition of effective contraception is provided in Section 4.4.
    5. Diagnostic evidence of probable AD consistent with DSM IV and NINCDS ADRDA criteria. The diagnosis of probable AD must be made by the site Physician at the time of the Screening visit. This evidence must be fully documented in the participant’s file (source documents) prior to the Baseline Visit.
    6. MRI (preferred) or CT (if MRI not feasible in the opinion of the Investigator) within the last 12 months consistent with a diagnosis of probable Alzheimer’s disease without any other clinically significant co morbid pathologies found. If there has been a significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, the scan should be repeated if considered appropriate by the Investigator. Subjects with MRI or CT indicating cortical infarct, strategically located subcortical gray matter infarct (eg, hippocampus, thalamus), multiple white matter lacunes or extensive white matter abnormalities should be excluded.
    7. Subjects with mild to moderate probable Alzheimer’s disease with a Mini Mental State Exam (MMSE) score between 14 26 inclusive at Screening.
    8. Subjects must be on donepezil 10 mg q day for at least 90 days prior to screening and be tolerating the medication well, without significant side effects, in the opinion of the investigator.
    9. Modified Hachinski Ischemia score ≤4.
    10. Subjects must live in the community and have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the Protocol, and ensure compliance with the study medication. The caregiver must be a constant and reliable informant. Subjects with moderate Alzheimer’s disease (MMSE 14-20) must reside with their caregiver. It is preferred that subjects with mild Alzheimer’s disease (MMSE 21-26) also reside with their caregiver but at a minimum the caregiver should have at least 4 hours of direct contact with such subjects 5 days per week.
    11. Subjects must be able to swallow oral medication in the form of tablets. Tablets are not to be crushed.
    12. Subjects with controlled hypertension (sitting systolic BP ≤160 mmHg and diastolic BP ≤95 mmHg) may be included in the study.
    13. Subjects’ screening 12 lead ECG must demonstrate predominantly normal sinus rhythm. QTcF must be ≤ 450 msec. Minor abnormalities (including sinus bradycardia
    ≤50 beats per minute) documented as clinically insignificant by the Investigator will be allowed. Subjects with right bundle branch block (complete or partial) or pacemakers may be included in the study, if considered clinically stable. Subjects with a history of atrial fibrillation are to be excluded.
    14. Subjects must be in reasonably good health in the opinion of the Investigator based on medical history, physical examination, vital signs, and 12 lead ECG with no serious or unstable disease within the past 3 months. Subjects with mild, chronic, stable disease (eg, controlled hypertension, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator.
    15. Subjects and caregivers must provide written Informed Consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
    16. Subjects with Type 2 diabetes stabilized by diet and/or oral hypoglycemic agents (3 months on a stable dose) are eligible provided they are medically managed by their treating Physician and monitored regularly to ensure adequacy of control. Subjects with known diabetes should have an HbA1C of ≤8% and a fasting serum glucose value of ≤170 mg/dl at Screening. Insulin use is not allowed.
    E.4Principal exclusion criteria
    Subjects presenting with any of following will not be included in study: 1.Presence of illness apart from AD that could contribute to cognitive dysfunction. Examples include other neurodegenerative disorders (eg, Lewy body dementia, fronto temporal dementia, vascular dementia); psychiatric disorders that meet DSM IV criteria for psychotic disorders, bipolar disorder, alcohol or substance abuse (occurring within the past 10 years);AIDS dementia; tertiary syphilis; or any form of dementia other than Alzheimer’s disease. 2. Current vitamin B12 level <271 pg/mL or 200 pmol/L, and elevated serum methylmalonic acid (MMA) level. 3.Active hyperthyroidism or hypothyroidism. Subjects with treated thyroid conditions who are clinically euthyroid and stable on treatment for at least 3 months prior to Screening may participate.. 4. Significant suicidal ideation with actual plan andintent or suicidal ideation and for whom it has been determined that it is unsafe to participate in this study. 5. Clinically significant cardiovascular disease in the 6 months prior to screening. Examples of clinically significant cardiovascular disease include myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), severe or unstable angina; serious intermittent arrhythmia, clinically significant ECG conduction abnormalities, and moderate to severe heart failure (NYHA Stage III/IV). 6.Orthostatic blood pressure changes or orthostatic symptoms (such as dizziness, light headedness, etc.) which are considered clinically significant by the investigator. Orthostatic hypotension is defined as a decrease of ≥20 mmHg for systolic blood pressure or ≥10 mmHg for diastolic blood pressure within 3 minutes of standing from the supine position. Lesser degrees of BP reduction may still be considered clinically significant if the subject becomes symptomatic upon standing, especially in the presence of a significant increase in heart rate (≥30 BPM). 7. Transient Ischemic Attack (TIA) in the past 3 months. 8. Clinically significant history of cerebrovascular accident (CVA) or stroke, other than incidental lacunar infarction in a nonsignficant location on brain imaging. 9. History of a seizure disorder. 10. Clinically significant pulmonary disease that requires treatment or results in clinically significant pulmonary symptoms (eg, interstitial lung disease, moderate or severe or unstable asthma, COPD [emphysema or chronic bronchitis], chronic or acute pneumonitis). If the subject has a past history of asthma but has not required treatment for 1 year, participation is allowed. 11. History of cancer within the last 5 years, other than treated localized basal cell or squamous cell carcinoma of the skin, and stable localized prostate cancer (carcinoma in situ) not requiring treatment. 12. Evidence or history of diabetes mellitus Type 1. 13. Subjects who are taking or are expected to use prohibited concomitant drugs or restricted concomitant drugs outside the guidelines provided in Appendix 3 and Section 5.5 unless permitted by agreement of sponsor. 14. Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding Screening. 15. Subjects intending to donate blood or blood components while receiving study medication or within 90 days after the last dose of study medication. Donation of approximately 1 pint [500 ml] of blood within 2 months prior to screening isalso excluded.16. Subjects with a total body weight <90 lb (40.9 kg). 17. Any clinically significant laboratory abnormalities at Screening. 18.Elevated transaminase levels and/or bilirubin of greater than 2 times the upper limit of normal (ULN). 19. Creatinine level >1.3. 20. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 oz of wine or 12 oz [360 mL] of beer or 1.5 oz [45 mL] of hard liquor) within 6 months of Screening. 21. Evidence or history of clinically significant severe allergic reactions to drugs (eg, severe cutaneous and/or systemic allergic reactions). 22. Subjects unable to complete the ADAS cog at the Screening Visit. 23. Significant sensory (such as severely impaired hearing or vision) or motor difficulties that would prevent participation in all aspects of the study. (A cane [walking stick] or walker is permitted). 24. Participation in any other studies in which the ADAS cog is used, or studies in which involve cognitive rehabilitation, either during the current study or within 1 month of the Screening visit. 25. Any other medical condition, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or that may interfere with the interpretation of study results and, that, in the judgment of the investigator, would make the subject inappropriate for entry into this study
    E.5 End points
    E.5.1Primary end point(s)
    Alzheimer’s Disease Assessment Scale Cognitive Subscale 70 (ADAS cog) 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Last Subject Last Visit
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    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)
    None, subjects will continue on standard of care
    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 Decision2010-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-10-28
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