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    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-024150-10
    Sponsor's Protocol Code Number:OPO-ALD-CHF-301
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-11
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-024150-10
    A.3Full title of the trial
    A-15 week, double-blind, randomized, active-controlled, multicenter study to evaluate the efficacy and safety of Alendronate plus Vitamin D3 in women with osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A-15 week, double-blind, randomized, active-controlled, multicenter study to evaluate the efficacy and safety of Alendronate plus Vitamin D3 in women with osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    Vit.D levels after alendronate plus vitamin D3 in postmenopausal women
    A.4.1Sponsor's protocol code numberOPO-ALD-CHF-301
    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 SponsorTeva Pharmaceutical Industries Ltd.
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointDr. Ekkehard Baader
    B.5.3 Address:
    B.5.3.1Street AddressWaldeckerstr. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number004961059767617
    B.5.5Fax number004961059767660
    B.5.6E-mailekkehard.baader@teva.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 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 nameAlendronate/cholecalciferol 70 mg/0.07 mg (Test 1)
    D.3.2Product code not applicable
    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 INNALENDRONIC ACID
    D.3.9.1CAS number 66376-36-1
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameALENDRONIC ACID
    D.3.9.4EV Substance CodeSUB05307MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameCHOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.07
    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 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 nameAlendronate/cholecalciferol 70 mg/0.14 mg (Test 2)
    D.3.2Product code not applicable
    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 INNALENDRONIC ACID
    D.3.9.1CAS number 66376-36-1
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameALENDRONIC ACID
    D.3.9.4EV Substance CodeSUB05307MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameCHOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.14
    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 Fosamax® 70 mg tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFosamax® 70 mg tablets (Reference)
    D.3.2Product code not applicable
    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 INNALENDRONIC ACID
    D.3.9.1CAS number 66376-36-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameALENDRONIC ACID
    D.3.9.4EV Substance CodeSUB05307MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    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
    D.8 Placebo: 3
    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
    Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
    E.1.1.1Medical condition in easily understood language
    Treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency.
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 main objective of the present trial is to estimate the proportion of patients with 25-hydroxy vitamin D insufficiency (<15 ng/ml) after 15 weeks of treatment with two oral test products containing alendronate sodium/cholecalciferol 70 mg/0.07 mg or 70 mg/0.14 mg (Alendronate/cholecalciferol (Teva Pharmaceutical
    Industries Ltd.)) as compared to alendronate alone Fosamax®.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the present trial are:
    - To evaluate the efficacy of both test products as compared to Fosamax® alone in reducing the proportion of patients with 25-hydroxy vitamin D deficiency (<9 ng/ml) after 15 weeks of treatment.
    - To assess the difference in the mean serum 25-hydroxy vitamin D between both test products and the reference product after 15 weeks of treatment.
    - To assess the percent change from baseline in the serum concentrations of intact serum parathyroid hormone (iPTH) between both test products and the reference product after 15 weeks of treatment.
    - To evaluate the changes from baseline in the rate of bone turnover as assessed by biochemical markers (bone-specific alkaline phosphatase (BSAP) and urine N-telopeptides of type 1 colloagen corrected for creatinine (NTx/Cr)).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 years and older
    2. Patients in good general health, according to the investigator‟s judgment
    3. Serum 25-hydroxy vitamin D ≥9 ng/ml
    4. Normal (within reference range) iPTH and BSAP for patients with serum 25-hydroxy vitamin D ≥9 ng/ml and <15 ng/ml
    5. Postmenopausal women defined as one of the following: - more than 6 months amenorrhea in patients ≥55 years OR - more than 18 months amenorrhea in patients <55 years OR - baseline serum FSH >35 IU/l in patients <55 years and less than 18 months amenorrhea OR - surgical menopause since more than 4 weeks.
    6. Recent (within the last 6 months) bone mineral density (BMD) Tscore determined by dual energy X-ray absorptiometry (DEXA) of either lumbar spine or hip of ≤ -2.5 (≥2.5 standard deviations below the mean for normal postmenopausal women)
    7. Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
    8. Patient agrees to avoid tanning beds/UV therapy within 14 days of study start, and during the study
    9. Patients with ability to follow study instructions and likely to attend and complete all required visits
    10. Written informed consent of the patient
    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substances or to any of the excipients, or to any related drug
    2. Bone fractures within 3 months prior to screening
    3. Inability to stand or sit upright for at least 30 minutes
    4. Inability to take the study drugs as recommended: after getting up for the day with a full glass of water (not less than 200 ml)
    5. Active upper gastrointestinal problems, such as dysphagia, esophageal disease, gastritis, duodenitis, ulcers
    6. Recent history (within the previous year) of major gastrointestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty
    7. Known Barrett's esophagus
    8. Malabsorption
    9. Hypocalcemia: serum calcium <2.1 mmol/l (9 mg/dl)
    10. Concomitant malignancy except carcinoma in situ not needing other than local therapy
    11. History of solid tumors not curatively treated or showing a recurrence within the last 5 years
    12. Concomitant untreated severe periodontal disease
    13. Renal impairment (glomerular filtration rate less than 35 ml/min)
    14. Presence of bone or mineral metabolism disorders, other than idiopathic osteoporosis (e.g. hyperparathyroidism, hyperthyroidism, osteomalacia of other origin, Paget‟s disease of bone, glucocorticoid-induced osteoporosis)
    15. Diseases associated with unregulated overproduction of calcitriol (e.g. leukemia, lymphoma, sarcoidosis).
    16. Previous or concomitant intake of drugs and/or food additives restricted by the protocol (for a complete list please see chapter 8.6.6, page 38).
    17. Pregnancy or lactation
    18. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
    19. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
    20. History of alcohol or drug addiction
    21. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
    22. Unreliability or lack of cooperation
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in the present trial is the proportion of patients with 25-hydroxy vitamin D insufficiency (<15 ng/ml) after 15 weeks of treatment. This endpoint undergoes descriptive and comparative statistical evaluation
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 15 weeks of treatment
    E.5.2Secondary end point(s)
    a) proportion of patients with 25-hydroxy vitamin D deficiency (<9 ng/ml) after 15 weeks of treatment,
    b) mean serum concentration of 25-hydroxy vitamin D after 15 weeks of treatment,
    c) percent change from baseline in intact serum parathyroid hormone (iPTH) after 15 weeks of treatment
    d) changes from baseline in the rate of bone turnover as assessed by biochemical markers (bone-specific alkaline phosphatase (BSAP) and urine N-telopeptides of type 1 colloagen corrected for creatinine (NTx/Cr))
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 15 weeks of treatment
    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 No
    E.6.7Pharmacodynamic No
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    verum-controlled with double dummy technique
    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 trial3
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    The clinical end of the trial is the last visit of the last subject undergoing the trial.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 630
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 630
    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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 630
    F.4.2.2In the whole clinical trial 630
    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)
    No plans for specific treatment or care after the subject has ended her participation in the trial.
    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 Decision2011-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-27
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