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    Summary
    EudraCT Number:2007-000425-22
    Sponsor's Protocol Code Number:68-4986/12484
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-12-20
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2007-000425-22
    A.3Full title of the trial
    Phase IIa Efficacy and Safety Trial of capadenoson in Patients with Chronic Stable Angina
    A.4.1Sponsor's protocol code number68-4986/12484
    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 SponsorBayer Healthcare AG
    B.1.3.4CountryGermany
    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 nameBay 68-4986
    D.3.2Product code Bay 68-4986
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNCapadenoson
    D.3.9.1CAS number 544417-40-5
    D.3.9.2Current sponsor codeBay 68-4986
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 nameBay 68-4986
    D.3.2Product code Bay 68-4986
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNCapadenoson
    D.3.9.1CAS number 544417-40-5
    D.3.9.2Current sponsor codeBay 68-4986
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 3
    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 nameBay 68-4986
    D.3.2Product code Bay 68-4986
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNCapadenoson
    D.3.9.1CAS number 544417-40-5
    D.3.9.2Current sponsor codeBay 68-4986
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboGranules for oral suspension
    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
    Patients with Chronic Stable Angina
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049194
    E.1.2Term Stable angina pectoris
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to demonstrate that chronic administration of BAY 68-4986 for 28 days at doses of 1 mg, 2 mg and 4 mg, is efficacious in a patient population with chronic stable angina and documented coronary heart disease. The primary efficacy parameter will be the total exercise time.
    E.2.2Secondary objectives of the trial
    The following secondary efficacy variables will be analysed descriptively by dose group for difference from baseline (ETT 2): total exercise time on Day 14 (ETT3), heart rate at rest, heart rate at trough drug concentration at comparable workload levels, heart rate during exercise at 1 mm ST-segment depression, time to 1 mm ST-segment depression, time to angina onset.
    The number of angina attacks and short acting nitrates usage characteristics (based on diary data) will also be analysed descriptively.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
    2. Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks
    3. ETT positive, within the previous 6 months, for myocardial ischemia (horizontal or downsloping ST segment depression of at least 1mm with respect to the isoelectric line, 80 msec after the J-point, occurring after at least 3 minutes of exercise on treadmill (according to the modified Bruce protocol) with stable ischemia threshold.
    4. CAD documented by at least one of the following:
    • more than 70% diameter stenosis in at least one of the epicardial coronary arteries on coronary angiography
    • previous PTCA/CABG (> 6 months)
    • previous MI (> 6 months)
    • typical angina in male subjects aged > 55 years, who have a positive stress test result (both by the ECG and clinical criteria)
    5. Subject´s written informed consent obtained at screening visit before any study-related procedures and before wash-out of pre-existing anti-anginal medication.
    E.4Principal exclusion criteria
    1. Inability to withdraw current anti-anginal therapy
    2. Inability to withdraw any concomitant therapy that would interfere with interpretation of study results
    3. More than 3 episodes of chest pain per day that require short-acting nitrates
    4. Vasospastic (Prinzmetal) angina
    5. Inability to perform an exercise on treadmill for least three minutes
    6. Myocardial infarction or unstable angina within the last 6 months
    7. PTCA or CABG performed within the last 6 months
    8. Known unprotected left main coronary artery disease
    9. Resting 12-lead ECG ST-segment depression greater than 0.5 mm or any other ECG findings that may interfere with interpretation of the ECG during ETT
    10. Significant ST-segment elevation at rest or during ETT in non-Q-wave leads
    11. Significant rhythm or conduction disorder:
     bradycardia on physical examination at rest (HR < 50/min)
     tachycardia on physical examination at rest (HR > 100/min)
     important or complex ventricular arrythmias (on investigators discretion)
     atrial fibrillation
     intraventricular conduction disorders
     sino-atrial, second degree or third degree A-V block
     baseline QTc > 450 msec
    12. Treatment with anti-arrythmic drugs
    13. Hypertension with systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg
    14. Postural hypotension
    15. Heart failure, NYHA Class II – IV (appendix 10.3)
    16. Severe cardiac valvular disease
    17. Significant pulmonary disease
    18. Significant peripheral vascular disease, e.g., Raynaud’s syndrome or intermittent claudication
    19. Stroke or TIA in the last 6 months
    20. Gross obesity (BMI > 35)
    21. Failure of a major organ system or a medical disorder that would impair the subject’s ability to complete this study (in the opinion of the investigator)
    22. Malignancy or disease known to markedly reduce the subjects life expectancy
    23. Significant mental illness
    24. History of epilepsy or other seizure disorders
    25. Known hypersensitivity to BAY 68-4986
    26. Concurrent use of CYP 2C9 substrates such as fluvastatin, warfarin, diclofenac, losartan, rosiglitazone, glibenclamide/glyburide, tolbutamide
    27. Liver function tests (AST, ALT, LDH) >2 times the upper limit of normal at screening (see also section 4.6.4)
    28. Creatine kinase (CK) levels > 3 times the upper limit of normal at screening (see section 4.6.4)
    29. Hematocrit value <32% at screening
    30. Blood donation within 30 days
    31. Serum creatinine >2.0 mg/dl or >177 micromol/L at screening (see section 4.6.4)
    32. Other abnormal laboratory parameters considered clinically significant (in the opinion of the investigator)
    33. Participation in an investigational drug study during which active medication was given within the last 30 days
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the absolute difference in total exercise time between ETT2 (baseline) and ETT4 (day 28). ETT will be performed at trough 24 hours post-dose.
    Secondary efficacy objectives will be the evaluation of the effect of BAY 68-4986 on the variables listed below, with absolute differences from baseline (ETT 2) being investigated:
    - total exercise time on Day 14 (ETT3)
    - time to 1 mm ST-segment depression
    - heart rate at rest
    - heart rates at trough drug concentration at comparable workload levels
    - heart rate during exercise at 1 mm ST-segment depression
    - time to angina onset
    The number of angina attacks and short-acting nitrates usage characteristics (based on diary data) will also be described.
    In addition, BAY 68-4986 exposure in all subjects will be assessed via sparse sampling and population pharmacokinetic approaches.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    different dosage of the same drug
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 visit of last patient undergoing trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 300
    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 Decision2007-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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