Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-000179-17
    Sponsor's Protocol Code Number:ikfe-Lina-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000179-17
    A.3Full title of the trial
    Effect of Linagliptin in comparison with Glimepiride as add on to Metformin on postprandial beta cell function, postprandial metabolism and oxidative stress in patients with type 2 diabetes mellitus
    Wirkung von Linagliptin im Vergleich mit Glimepirid als zusätzliche Medikation zu Metformin auf postprandiale Beta Zellfunktion, postprandialen Metabolismus und oxidativen Stress in Patienten mit Typ 2 Diabetes Mellitus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Linagliptin in comparison with Glimepiride as add on to Metformin on the metabolism of diabetic patients after a meal.
    Wirkung von Linagliptin im Vergleich mit Glimepirid als zusätzliche Medikation zu Metformin auf den Stoffwechsel von Patienten mit Diabetes nach dem Essen.
    A.4.1Sponsor's protocol code numberikfe-Lina-002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorikfe GmbH
    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 supportBoehringer Ingelheim Pharma GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationikfe CRO GmbH
    B.5.2Functional name of contact pointContract Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressBahnhofstraße 8a
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55116
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 61313279032
    B.5.5Fax number+4961313279036
    B.5.6E-mailC.Forkel@ikfe-cro.de
    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 Yes
    D.2.1.1.1Trade name Trajenta
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 668270-12-0
    D.3.9.3Other descriptive nameLINAGLIPTIN
    D.3.9.4EV Substance CodeSUB31340
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Glimepirid-ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479-97-1
    D.3.9.4EV Substance CodeSUB07925MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Glimepirid-ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNGLIMEPIRIDE
    D.3.9.1CAS number 93479-97-1
    D.3.9.4EV Substance CodeSUB07925MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes mellitus type 2 on metformin therapy
    Diabetes mellitus Typ 2 mit Metformin Therapie
    E.1.1.1Medical condition in easily understood language
    Diabetes mellitus type 2
    Diabetes mellitus Typ 2
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the effect of Linagliptin in comparison to Glimepiride, on several parameters characterizing postprandial metabolism and oxidative stress in type 2 diabetic patients on stable control with metformin.
    Das Ziel dieser Studie besteht in der Erforschung der Wirkung von Linagliptin im Vergleich mit Glimepiride auf verschiedene Parameter des postprandialen Metabolismus und oxidativen Stress bei Typ 2 Diabetikern mit stabiler Einstellung durch Metformin.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diabetes mellitus type 2
    2. HbA1c ≥ 6.5% - ≤ 8.5%
    3. HbA1c ≥ 7.0% - ≤ 8.5% for those patients with a significant cardiovascular history
    4. Treatment with metformin at a maximum tolerated dose
    5. Age 45 – 75 years (inclusively)
    6. Patient consents that his/her family physician/diabetologist will be informed of trial participation.
    1.1. Diabetes mellitus Typ 2
    2. HbA1c > 6.5% < 8.5%
    3. HbA1c > 7.0 < 8.5 % für Patienten mit medizinischer Vorgeschichte signifikanter kardiovaskulärer Erkrankung
    4. Behandlung mit Metformin in maximal tolerierter Dosierung
    5. Alter 45 – 75 (inklusive) Jahre
    6. Patient erklärt sich einverstanden, dass der Hausarzt über die Studienteilnahme informiert wird.
    E.4Principal exclusion criteria
    11. Pretreatment with PPAR gamma agonists within the last three months
    2. History of type 1 diabetes
    3. Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg)
    4. Acute infections
    5. Medical history of hypersensitivity to the study drugs or to drugs with similar chemical structures
    6. History of severe or multiple allergies
    7. Treatment with any other investigational drug within 3 months before trial entry.
    8. Progressive fatal disease
    9. History of drug or alcohol abuse in the past 2 years
    10. State after kidney transplantation
    11. Serum potassium > 5.5 mmol/L
    12. Pregnancy or breast feeding
    13. Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomized partner.
    14. Acute myocardial infarction, open heart surgery or cerebral event (stroke/TIA) within the previous 30 days
    15. Any elective surgery during study participation
    16. Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit
    17. History of pancreatitis
    18. History of dehydration, pre-coma diabeticum or diabetic ketoacidosis
    19. Acute or scheduled investigation with iodine containing radiopaque material
    20. Uncontrolled unstable angina pectoris
    21. History of pericarditis, myocarditis, endocarditis
    22. Recent pulmonary embolism
    23. Hemodynamic relevant aortic stenosis
    24. Aortic aneurysm
    25. Regular use of NSAID’s (no acute use of NSAID within 48 hours before V2,V4,V5)
    26. Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
    27. History of respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (Creatinine > 1.1 mg/dl in women and > 1.5 mg/dl in men ), neurological, psychiatric and/or hematological disease as judged by the investigator
    28. Lactose intolerance
    29. Intake of Coumarin or coumarin derived compounds such as phenprocoumon (Marcumar) or warfarin (Coumadin, Warfant)
    11. Vorbehandlung mit PPAR Gamma Agonisten innerhalb der letzten 3 Monate
    2. Anamnese mit Diabetes Mellitus Typ 1
    3. Unkontrollierte Hypertension (systolischer Blutdruck > 160 mmHg und/oder diastolischer Blutdruck > 90 mmHg)
    4. Akute Infektionen
    5. Anamnese mit Überempfindlichkeit gegenüber der Studienmedikation oder Medikamenten mit ähnlicher chemischer Struktur
    6. Anamnese schwerer oder multipler Allergien
    7. Behandlung mit einer anderen Studienmedikation innerhalb der vergangenen 3 Monate vor Studieneinschluss
    8. Fortschreitende, tödliche Erkrankung
    9. Anamnese mit Drogen oder Alkohol Missbrauch während der letzten 2 Jahre
    10. Zustand nach Nierentransplantation
    11. Serum Kalium > 5.5 mmol/L
    12. Schwangerschaft oder Stillzeit
    13. Sexuel aktive Frauen im gebährfähigen Alter ohne korrekt – und durchgängig angewandte hoch effektive Kontrazeption mit geringer Fehlerrate (dh. weniger als 1% p.a.) wie Implantate, Injektionen, kombinierte orale Kontrazeptiva, hormonale Intrauterinpessare, sexuelle Abstinenz oder vasektomiertem Partern.
    14. Akuter Myokardinfarkt, Operation am offenen Herzen oder zerebralem Vorkomniss (Schlaganfall, TIA) innerhalb der vergangenen 30 Tage
    15. Jegliche freiwillige Operation während der Studienteilnahme
    16. Auftreten mehr als eines unerklärlichen Vorkomnisses schwerer Hypoglykämie (definiert durch die Notwendigkeit von Fremdhilfe aufgrund zu Handlungsunfähigkeit führender Hypoglykämie) innerhalb der letzten 6 Monate vor der Screening Visite
    17. Anamnese mit Pankreatitis
    18. Anamnese mit Dehydration, Präkomadiabetikum oder diabetischer Ketoazidose
    19. Akute oder geplante Untersuchung mit Kontrastmittel welches Iod enthielt
    20. Unkontrollierte, instabile Angina Pektoris
    21. Anamnese mit Perikarditis, Myokarditis oder Endokarditis
    22. Kürzliche pulmonare Embolie
    23. Hämodynamisch relevante Aortenstenose
    24. Aortenaneurisma
    25. Regelmäßige Einnahme von NSAID’s (nicht akute Einnahme von NSAID innnerhalb der letzten 48 Std. vor V2, V4, V5)
    26. Mangelnde Compliance oder ähnlicher Grund welcher nach Einschätzung des Arztes eine befriedigende Teilnahme ausschließt
    27. Anamnese signifikanter respiratorischer, gastrointestinaler, hepatischer (ALAT und/ASAT > 3 fachen des Referenzwertes), renaler (Creatinine > 1.1 mg/dl bei Frauen und > 1.5 mg/dl bei Männern), neurologischer, psychiatrischer und/oder hämatologischer Erkrankungen im Ermessen des Arztes
    28. Laktoseintoleranz
    29. Einnahme von Kumarin oder Kumarinderivaten wie z. B. Marcumar oder Warfarin
    E.5 End points
    E.5.1Primary end point(s)
    • Postprandial increase in intact Proinsulin levels (Peak, AUC)
    • Postprandial Proinsulin/Insulin Ratio
    • Fasting intact Proinsulin levels
    • Fasting Proinsulin/Insulin Ratio
    • Fasting Blood Glucose
    • Postprandial Blood Glucose Excursions (Peak; AUC)
    • Fasting Lipids (Total Cholesterol, HDL, LDL, Triglycerides, FFA, oxLDL, small particle LDL)
    • Postprandial Lipids (Triglycerides, FFA)
    • Fasting Erythrocyte Flexibility
    • Postprandial Erythrocyte Flexibility
    • Fasting GLP-1 levels
    • Postprandial GLP-1 levels
    • Fasting cGMP
    • Postprandial cGMP
    • Fasting Calcitonin
    • Fasting PAI-1 levels
    • Postprandial PAI-1 levels
    • Fasting ADMA levels
    • Postprandial ADMA levels
    • Fasting Malonyldialdehyd
    • Fasting Urine sample for measurement of oxidatively modified nucleosides 8-oxodG and 8-oxoGuo
    • Postprandialer Anstieg intaktes Proinsulin Level (Peak, AUC)
    • Postprandialer Proinsulin/Insulin Ratio
    • Nüchtern intakte Proinsulin Level
    • Nüchtern Proinsulin/Insulin Ratio
    • Nüchtern Blutzucker
    • Postprandialer Blutzucker Exkursionen (Peak; AUC)
    • Nüchtern Lipide (Total Cholesterin, HDL, LDL, Triglyzeride, FFA, oxLDL, small particle LDL)
    • Postprandiale Lipide (Triglyzeride, FFA)
    • Nüchtern Erythrozyten Flexibilität
    • Postprandiale Erythrozyten Flexibilität
    • Nüchtern GLP-1 Level
    • Postprandiale GLP-1 Level
    • Nüchtern cGMP
    • Postprandiale cGMP
    • Nüchtern Kalzitonin
    • Nüchtern PAI-1 Level
    • Postprandiale PAI-1 Level
    • Nüchtern ADMA Level
    • Postprandiale ADMA Level
    • Nüchtern Malonyldialdehyd
    E.5.1.1Timepoint(s) of evaluation of this end point
    after approx. 14 weeks of treatment
    nach ~ 14 Wochen Behandlung
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    mechanistic, exploratory
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    After 5 study visits, approx. 14 weeks of treatment
    nach 5 Studienvisiten, etwa 14 Wochen Behandlung
    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 months6
    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 months6
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    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 state40
    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)
    Special post trial treatment is not planned. Patient will either get back to the routine therapy or will adapt his/ her therapy as one of the used medications is available on the German market.
    Eine spezielle Nach-Studien-Therapie ist nicht vorgesehen. Der Patient wird entweder zur seiner Ursprungs-Therapie zurückkehren oder seine Therapie adaptieren, da ein verwendetes Medikament auf dem deutschen Markt erhältlich ist.
    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 Decision2012-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-25
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 06:27:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA