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    Summary
    EudraCT Number:2007-005474-31
    Sponsor's Protocol Code Number:AT305-X-06-004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-12-18
    Trial 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 ConcernedDenmark - DHMA
    A.2EudraCT number2007-005474-31
    A.3Full title of the trial
    A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-305 Administered for Six Months in Postmenopausal Women with Osteoporosis
    A.4.1Sponsor's protocol code numberAT305-X-06-004
    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 SponsorAkros Pharma 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.3.1Product nameJTT-305
    D.3.2Product code JTT-305
    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.3.9.1CAS number 787584-79-6
    D.3.9.2Current sponsor codeJTT-305
    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.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
    Osteoporosis in postmenopausal women
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of JTT-305 on the changes in lumbar spine bone mineral density (BMD), as determined by dual energy X-ray absorptiometry (DXA), when administered for 24 weeks to postmenopausal women with osteoporosis.
    E.2.2Secondary objectives of the trial
    • To determine the effect of JTT-305 on the changes in hip BMD (femoral neck, shaft, trochanter, total hip), as determined by DXA, when administered for 24 weeks to postmenopausal women with osteoporosis.
    • To determine the effect of JTT-305 on the changes in bone turnover markers when administered for 24 weeks to postmenopausal women with osteoporosis.
    • To examine the safety profile of JTT-305 when administered for 24 weeks to postmenopausal women with osteoporosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ambulatory postmenopausal women, between 45-80 years of age (inclusive) at the Screening Visit (Visit 1), who are able to provide written informed consent;
    2. Females who are currently postmenopausal as defined by:
    • No menstrual cycle for 60 consecutive months and no other biological or physiological cause for this phenomenon can be identified, or
    • A medical history of bilateral oophorectomy occurring at least 60 months prior to the Screening Visit;
    3. A body mass index (BMI) between 18-32 kg/m2 (inclusive) at the Screening Visit;
    4. Body weight > 40 kg at the Screening Visit;
    5. A bone mineral density (BMD) T-score of ≤ -2.5 (BMD ≤ 0.880 g/cm2) at the lumbar spine, or BMD T-score ≤ -2.0 (BMD ≤ 0.940 g/cm2) at the lumbar spine with at least one of the following: at least 65 years of age, history of at least 10 consecutive years of smoking, BMI < 20 kg/m2, history of postmenopausal osteoporotic fracture (vertebral or non-vertebral), or maternal history of osteoporotic fracture (vertebral or non-vertebral), at the Screening Visit;
    6. Vitamin D (25-OH-D) levels ≥ 50 nmol/L prior to Visit 5;
    7. Have at least two evaluable vertebrae in L1 - L4 for BMD measurements by DXA.
    E.4Principal exclusion criteria
    1. More than one severe fracture or more than two mild or moderate fractures in T4 – L4 at the Screening Visit (see Appendix 1 for the grading scale);
    2. A BMD T-score of < -4.0 (BMD < 0.700 g/cm2) at the lumbar spine or a BMD T-score of < -4.0 at the hip (average of two measurements of either the total hip [BMD < 0.520 g/cm2] or femoral neck [BMD < 0.500 g/cm2]);
    3. Severe calcification on ligaments around L1 – L4 and/or on abdominal aorta, or excessive degenerative disease (e.g., osteophytes, sclerosis) which precludes accurate measurement of lumbar spine BMD in at least two vertebrae;
    4. Secondary osteoporosis (i.e., osteoporosis due to underlying diseases or chronic conditions that contribute to accelerated bone loss, including (but not limited to) genetic disorders, hypogonadal states, endocrine disorders, hematologic disorders, nutritional deficiencies, and/or drugs);
    5. Serum corrected calcium > 2.55 mmol/L, or serum phosphorus levels ≥ 1.61 mmol/L or ≤ 0.80 mmol/L at the Screening Visit;
    6. Abnormal reference laboratory values for intact parathyroid hormone or thyroid stimulating hormone (TSH) at the Screening Visit;
    7. Abnormal liver functions as measured by AST or ALT > 1.5 x ULN, or total bilirubin > 2.0 x ULN at the Screening Visit;
    8. A serum follicle stimulating hormone (FSH) level < 40.0 IU/L at the Screening Visit;
    9. Positive results for Hepatitis B sAg, Hepatitis C antibody, Hepatitis A IgM or HIV Viral Serology tests at the Screening Visit;
    10. A history of drug abuse within 12 months preceding the Screening Visit;
    11. A history of alcohol abuse within 12 months preceding the Screening Visit. Alcoholism is defined as the consumption of more than 28 units of alcohol a week (an alcohol unit is defined as 300 mL of beer, 100 mL of wine, or 25 mL of hard liquor);
    12. A medical history of hyperparathyroidism or hypoparathyroidism;
    13. Current uncontrolled hyperthyroidism or hypothyroidism (see Appendix 2);
    14. A medical history of parathyroidectomy;
    15. A medical history of complete or partial thyroidectomy without original documentation that the parathyroid glands remain intact;
    16. A medical history of other bone or calcium metabolic disorders (e.g., Paget’s Disease, osteomalacia, malabsorption syndrome, or severe scoliosis);
    17. A medical history of type 1 diabetes, current uncontrolled type 2 diabetes (defined as hemoglobin A1c > 8%), or current use of insulin (see Appendix 2);
    18. Current, or a history of (within the previous five years), calcium-containing nephrolithiasis or urolithiasis, or significant renal impairment (e.g., serum creatinine > 177 μmol/L);
    19. A clinically relevant history of, in the opinion of the Investigator, or presence of cardiovascular, dermatological, endocrinological, gastrointestinal, hematological, hepatic, immunological, lymphatic, musculoskeletal, neurological, psychiatric, renal, or respiratory disease;
    20. Current, or a history of (within the previous five years), malignancy (except for treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix);
    21. Previous skeletal exposure to external beam radiotherapy (i.e., radiation therapy);
    22. A significant history of drug sensitivities (i.e. multiple drug allergies or severe allergic reactions) in the opinion of the Investigator;
    23. Hypersensitivity to any component of JTT-305, Calcichew-D3 Forte®, or D3-Vitamin® formulations, in the opinion of the Investigator;
    24. Cannot communicate reliably with the Investigator or staff;
    25. Are unlikely to cooperate with the requirements of the study, including the previous and concomitant medication restrictions (see Appendices 2 and 3) and diet restrictions (see Section 3.5.10), in the opinion of the Investigator;
    26. A history of non-compliance with research protocols.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percent change from baseline to the end of treatment (EOT) in lumbar spine BMD.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The end of the clinical study is defined as the date of the last subject’s last visit. The study may also be terminated at any time at the request of Akros or the Investigator with proper and timely notification of all parties concerned. The IRB/IEC will be informed promptly and reasons for the termination or suspension will be provided by the Investigator, as specified by the applicable regulatory requirements.
    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
    E.8.9.2In all countries concerned by the trial years1
    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 No
    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 state220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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 Decision2008-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-09-26
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