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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2005-004032-48
    Sponsor's Protocol Code Number:D6160C00058
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-12-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-004032-48
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Effect of Tesaglitazar 1 mg once daily on the Pharmacokinetics of Metformin Following Addition of Tesaglitazar to Metformin Treatment twice daily in Patients with Type 2 Diabetes
    A.4.1Sponsor's protocol code numberD6160C00058
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameTesaglitazar
    D.3.2Product code AZ242
    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.3.8INN - Proposed INNTesaglitazar
    D.3.9.1CAS number 251565-85-2
    D.3.9.2Current sponsor codeAZ242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name GLUCOPHAGE 500 mg filmdragerad tablett
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Santé s.a.s
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameGLUCOPHAGE
    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.3.8INN - Proposed INNMetforminhydroklorid
    D.3.9.1CAS number 657-24-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name GLUCOPHAGE 850 mg filmdragerad tablett
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Santé s.a.s
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameGLUCOPHAGE
    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.3.8INN - Proposed INNMetforminhydroklorid
    D.3.9.1CAS number 657-24-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 4
    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 Information not present in EudraCT
    D.2.1.1.1Trade name GLUCOPHAGE 1000 mg filmdragerad tablett
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Santé s.a.s
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameGLUCOPHAGE
    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.3.8INN - Proposed INNMetforminhydroklorid
    D.3.9.1CAS number 657-24-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type II Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of 1 mg tesaglitazar once daily versus placebo once daily given as add?on therapy to metformin on the steady state exposure (AUCss) of metformin in patients with type 2 diabetes with a serum creatinine within normal range and having CrCL>70 mL/min or CrCL≤70 to ≥50mL/min, by assessment after a 12-week randomized treatment period.
    E.2.2Secondary objectives of the trial
    1.Compare effect of 1 mg tesaglitazar once daily versus placebo once daily given as addon therapy to metformin on the pharmacokinetics of metformin in patients with type 2 diabetes with a serum creatinine within normal range and having CrCL>70 mL/min or CrCL≤70 to ≥50mL/min, by assessment of Css,max, tss,max, Css,min and CLR of metfomin, after a 12-week randomized treatment period.
    2.Compare the effects of 1 mg tesaglitazar once daily versus placebo once daily given as add-on therapy to metformin on GFR, in patients with type 2 diabetes with a serum creatinine within normal range and having CrCL>70 mL/min or CrCL≤70 to ≥50mL/min, by assessment of plasma clearance of 51Cr-EDTA, and endogenous CrCL after a 12-week randomized treatment period.
    3.Evaluate the safety and tolerability of 1 mg tesaglitazar once daily given as add-on therapy to metformin, by assessment of AEs, laboratory values, ECG, pulse, blood pressure, hypoglycaemic events, body weight and physical examination.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Provision of a written informed consent at Visit 1
    2.Men or women who are ≥18 years of age at time of consenting upon Visit 1
    3.Female patients who are post menopausal, have undergone a hysterectomy, or if of childbearing potential, are using an effective method of birth control
    Post menopausal patients are defined as patients with:
    -Natural or induced menopause with last menstruation >1 year ago, or
    -Bilateral oophorectomy
    A highly effective method of birth control is defined as combination oral contraceptive, implant, long term injectable contraceptive, intrauterine device or tubal ligation. However, female patients using oestrogen containing hormonal anti conception methods (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional anti conception method.
    4.Diagnosed with type 2 diabetes. For patients <30 years the C-peptide level in conjunction with the onset of diabetes should be >0.8 ng/mL, 0.27 nmol/L.
    5.FPG ≤13.3 mmol/L, 240 mg/dL
    6.Treated with metformin alone for the last three months or more, or treated with metformin for the last three months plus one additional oral anti-diabetic agent in low dose (maximal daily dose of metformin 2.7 g/day). The additional anti-diabetic medication is required to be discontinued at the enrolment visit. The low doses of additional anti-diabetic medication are defined as a maximal daily dose of sulphonylurea comparable to glibenclamide/glyburide 5 mg (corresponding to 3.5 mg of Swedish microcristal form of glibenclamide), meglitinide comparable to repaglinide 1.5 mg or alpha-glucosidase inhibitors comparable to acarbose 150 mg.
    Inclusion criteria at randomisation (Visit 2):
    7.HbA1c ≤8.5 %
    8.Mean FPG of two measurements (values from Visit 1 and 2, measured capillary) ≤11.7 mmol/L, 210 mg/dL
    E.4Principal exclusion criteria
    1.Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
    2.Active arterial disease such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular accident, myocardial or peripheral vascular disease revascularization or angioplasty within 24 weeks prior to Visit 1
    3.Pre-existing chronic heart failure (NYHA class I-IV)
    4.High blood pressure (mean systolic blood pressure ≥160 mm Hg, mean diastolic blood pressure ≥90 mm Hg after 3 repeated measurements) with or without anti-hypertensive treatment.
    5.History of thyroid ophthalmopathy
    6.History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
    7.History of blood lipid induced eruptive xanthomas, or hypertriglyceridaemia induced pancreatitis
    8.Suspected untreated proliferative diabetic retinopathy, as judged by the investigator
    9.Other conditions predisposing for development of lactatic acidosis, eg, chronic obstructive pulmonary disease (COPD)
    10.Pregnant or breastfeeding patients
    11.Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4 (See Appendix C)
    12.Treatment of type 2 diabetes with combination therapy (ie, additional antidiabetic agents, except low dose of 1 oral antidiabetic agent, see Section 3.4.5)
    13.Treatment with chronic insulin, within 24 weeks prior to Visit 1 (however, 1 temporary period of daily insulin injections no longer than 7 days is allowed)
    14.Treatment with a thiazolidinedione (eg, pioglitazone, rosiglitazone) within 4 weeks prior to Visit 1
    15.Treatment with fibrates, within 4 weeks prior to Visit 1
    16.Treatment with glucocorticoids (equivalent to oral prednisolone >10 mg per day), within 4 weeks prior to Visit 1
    17.Treatment with probenecid that can not be stopped at Visit 1
    18.History of hypersensitivity or intolerance to any PPAR agonist
    19.History of drug-induced myopathy or drug-induced CK elevation
    20.History of drug-induced liver enzyme elevations
    21.History of drug-induced neutropenia
    22.History of alcohol or drug abuse within the last 5 years
    23.Other serious or unstable medical or psychological condition identified in the patients’ medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
    24.Receiving any investigational product during the last 12 weeks prior to Visit 1
    25.Previous enrolment in this study
    26.Any clinically significant abnormality identified on physical examinations, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients’ safety or successful participation in the Clinical Study
    27.Other serious or unstable medical or psychological condition identified in the patients’ medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
    28.Fasting TG >7.0 mmol/L, 620 mg/dL
    29.Hb <90 g/L, 9 g/dL
    30.ANC <1.0x 109/L
    31.Any of ALT, AST or ALP >2.5 times the upper limit of normal
    32.Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome
    33.Creatinine > 135 μmol/L for men or > 110 μmol/L for women
    34.Calculated creatinine clearance <50 mL/min (estimated by the Cockcroft-Gault equation)
    35.CK >3 times the upper limit of normal
    36.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    E.5 End points
    E.5.1Primary end point(s)
    This study has no end points, however the primary variable is:
    AUCss of metformin during the last day-time 12-h dosing interval after 12-week treatment with metformin and tesaglitazar as compared to treatment with metformin and placebo in patients with type 2 diabetes with CrCL>70 mL/min or CrCL≤70 to ≥50mL/min.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 No
    E.8.1.6Cross over Yes
    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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    End of study is defined as date of database lock, which is the time point after which no patient will be exposed to study related activities.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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 Information not present in EudraCT
    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 2005-12-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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 Decision2006-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-01-09
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