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    Summary
    EudraCT Number:2012-003426-24
    Sponsor's Protocol Code Number:CTU079G
    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:2012-10-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-003426-24
    A.3Full title of the trial
    A multicentre double blind placebo controlled clinical trial to assess efficacy and safety of Alvalin® (cathine hydrochloride) vs. placebo in 265 obese patients/group with a body mass index (BMI) between 30 and 45 kg/m2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess efficacy and safety of Alvalin® (active agent) vs. placebo (inactive substance) in 265 obese patients/group with a body mass index (BMI) between 30 and 45 kg/m2. Neither the investigator nor the participant are aware of the nature of the treatment the participant is receiving. The trial is conducted in several trial centres.
    A.4.1Sponsor's protocol code numberCTU079G
    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 SponsorRiemser Pharma 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 supportRIEMSER Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRIEMSER Pharma GmbH
    B.5.2Functional name of contact pointMedical Science & Operations
    B.5.3 Address:
    B.5.3.1Street AddressAn der Wiek 7
    B.5.3.2Town/ cityGreifswald - Insel Riems
    B.5.3.3Post code17493
    B.5.3.4CountryGermany
    B.5.4Telephone number+4938351760
    B.5.5Fax number+493835176778
    B.5.6E-mailinfo@riemser.com
    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 ALVALIN
    D.2.1.1.2Name of the Marketing Authorisation holderSCHUCK 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 Oral drops, solution
    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 INNCATHINE
    D.3.9.1CAS number 492-39-7
    D.3.9.3Other descriptive nameD-Norpseudoephedrine
    D.3.9.4EV Substance CodeSUB06158MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboOral drops, solution
    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
    diet-related obesity diagnosed by BMI of 30 to 45 kg/m²
    E.1.1.1Medical condition in easily understood language
    diet-related obesity diagnosed by BMI of 30 to 45 kg/m². BMI is a measurement obtained by dividing a person's weight in kilograms by the square of the person's height in metres.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary endpoint is the weight reduction of at least 10% overall in the treatment group with at least 5% greater weight reduction than in the placebo group) after 52 weeks of treatment.
    E.2.2Secondary objectives of the trial
    SECONDARY ENDPOINTS :
    • • percentage of patients with weight loss > 5 %
    • percentage of patients with weight loss > 10 %
    • weight loss in kg
    • serum lipids
    • plasma glucose, HbA1C
    • change in waist circumference (WC)
    • change in waist-hip ratio (WHR)
    • change in body mass index (BMI)
    • dose-reduction or complete withdrawal of concomitant medication for obesity-related co-morbidities
    • overall assessment of efficacy by physician and by patient
    • quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • male and female patients, aged 18-65 years
    • caucasian origin
    • diet-related obesity diagnosed by BMI of 30 to 45 kg/m²
    • blood pressure after 5 min sitting at rest : <160/<90 mmHg
    • resting pulse rate after 5 min sitting at rest: <90 min-1
    E.4Principal exclusion criteria
    Specific:
    • weight gain or loss of > 3 kg, use of a very-low-calorie diet, or participation in a formal weight loss program within the past three months
    • previous bariatric surgery
    cardiovascular diseases: e.g.
    o history of stroke
    o myocardial infarction
    o life-threatening arrhythmia
    o coronary revascularization
    o angina pectoris
    o heart failure: NYHA classification stage 3 and 4
    o known clinical relevant coronary heart disease
    o known clinical relevant reduction of left ventricular function
    o serious arrhythmia
    o inflammatory heart disease
    o valvular heart disease
    o transient ischemic attack (TIA)
    o peripheral arterial disease
    o cerebrovascular disease
    • Neurologic
    o previous or current mental diseases, including anorexia nervosa and depression
    o current Hospital Anxiety and Depression Scale (HADS) score >11
    o recent (previous 6 months) suicide attempt or ideation with some intent to act
    • history of narrow angle glaucoma
    • history of any cancer
    • untreated hypothyroidism : TSH >1.5x upper limit of normal (ULN), signs or symptoms of hypothyroidism, use of thyroid hormone treatment that was not stable for at least three months
    • hyperthyroidism
    • known history of pulmonary hypertension
    • diabetes type 1
    • phaeochromocytoma
    • cushing’s syndrome or intake of glucocorticoids if the duration of the therapy surpasses the duration of an acute short term therapy
    • impaired kidney function: serum serum creatinine levels >1.4 mg/dL for women, >1.5 mg/dL for men
    • hepatic impairment: clinically significantly AST or ALT or γ-glutamyltransferase >3x ULN
    • insomnia
    • cut off limit in patients with coexisting risk factors like hyperlipidaemia and type 2 diabetes mellitus
    o full blood glucose (fasting) > 200 mg/dL (11.1 mmol/L)
    o HbA1c > 8,5 % (69,4 mmol/mol)
    o triglycerides > 800 mg/dL (9.14 mmol/L)
    o and at the discretion of the investigator
    • other severe systemic concomitant diseases
    • intake of drugs which have an impact on cathine action (see table 1 )
    • known intolerance to cathine, or other ingredients of the test/reference drug
    • high caffeine consumption (> 6 cups / day) or intake of caffeine –containing softdrings > 1,5L
    • known clinically relevant coronary heart disease
    • known clinically relevant reduction of left ventricular function
    • serious arrhythmia
    • tendency to misuse of medication or alcohol dependency.
    General:
    • female patients only: pregnancy or lactation, insufficient contraception
    • suspected/confirmed drug/alcohol addiction and abuse
    • current or previous participation in another clinical trial within 12 weeks preceding the start of the study
    • legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
    • unreliability or lack of cooperation and compliance

    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is the weight reduction after 52 weeks of treatment calculated as percentage of body weight lost.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    • percentage of patients with weight loss > 5 %
    • percentage of patients with weight loss > 10 %
    • weight loss in kg
    • serum lipids
    • plasma glucose, HbA1C
    • change in waist circumference (WC)
    • change in waist-hip ratio (WHR)
    • change in body mass index (BMI)
    • dose-reduction or complete withdrawal of concomitant medication for obesity-related co-morbidities
    • overall assessment of efficacy by physician and by patient
    • quality of life

    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    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 No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned18
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 530
    F.1.3Elderly (>=65 years) No
    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 state530
    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)
    anthropometric measures (weight, height, waist and hip circumference) and the health status of patients will be examined 3 and 12 month after end of treatment
    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 Decision2013-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-05
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