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    Summary
    EudraCT Number:2005-002454-21
    Sponsor's Protocol Code Number:014
    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:2005-06-22
    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 number2005-002454-21
    A.3Full title of the trial
    A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK-0364) in Obese Patients Followed by a 1-Year Extension
    A.3.2Name or abbreviated title of the trial where available
    Taranabant: 1-Yr Weight Loss Followed by 1-Yr Prevention of Weight Regain with 1-Year Extension
    A.4.1Sponsor's protocol code number014
    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 SponsorMerck Sharp & Dohme (Sweden) 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 nameTaranabant
    D.3.2Product code Taranabant
    D.3.4Pharmaceutical form Capsule*
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeTaranabant
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2, 4
    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 placeboCapsule*
    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
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In obese patients: 1) Safety and tolerability during treatment. 2) To assess the effect of 52 wks of treatment with taranabant 4 mg, relative to placebo, on body weight. 3) After treatment with taranabant 6 mg, to assess the effect of 52 weeks of treatment with taranabant 2 mg on prevention of weight regain, relative to placebo
    E.2.2Secondary objectives of the trial
    In obese pts:
    1. To assess effect of 52 wks trt with taranabant (MK364) 4 mg, relative to plbo, on: a) waist circumference (WC); b) metabolic syndrome (MS); c) biochemical markers (triglycerides, HDL-C, non-HDL-C, LDL-C, total cholesterol, fasting insulin, fasting plasma glucose, and insulin sensitivity); d) blood pressure (BP); e) patient reported outcomes (PRO)
    2. After trt with MK364 6 mg, assess effect of 52 wks of trt with MK364 2 mg, relative to pbo, on: a) WC; b) MS; c) biochemical markers; d) BP; (e) PRO
    3. In pts who complete 52 wks of trt on pbo or MK364 4 mg, assess the effect of 52 additional wks of trt with MK364 4 mg, relative to pbo, on: a) body weight; b) WC; c) MS; d) biochemical markers; e) BP; f) PRO
    4. In pts who experienced weight loss on MK364 6 mg, to assess effects of MK364 2 mg after 52 wks on: a) proportion who maintain the loss of ≥5% of their initial body weight; b) proportion who maintain ≥75% of the weight loss induced by MK364 6 mg
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Body mass index (BMI) between 30 kg/m2 and 43 kg/m2
    Patient meets at least 1 of the following 4 criteria:
    • Triglyceride levels ≥ 150 mg/dL (1.69 mmol/L) but ≤ 600 mg/dL (6.8 mmol/L)
    • HDL-C levels < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) in women
    • Seated systolic blood pressure ≥ 130 mm Hg or seated diastolic blood pressure ≥ 85 mm Hg
    • Impaired fasting glucose (FPG ≥ 100 mg/dL [5.5 mmol/L] and < 126 mg/dL [7.0 mmol/L])
    Patient is ≥ 18 years of age.
    Patient is highly unlikely to conceive
    Patient is able to read and understands the study procedures and agrees to participate in the study by giving written informed consent.
    E.4Principal exclusion criteria
    • Patients with a history or presence of a major DSM-IV-TR psychiatric disorder.
    • Patients with recent (within 6 months prior to screening) diagnosis/episode/ recurrence of stroke or neurological.
    • Patients with inadequately controlled hypertension.
    • Patients with a history of seizures or is at high risk of developing seizures (e.g. those with history of brain tumors, severe head trauma, or intracranial hemorrhage).
    • Patients with diabetes mellitus as defined by medical history, or a fasting blood glucose ≥126 mg/dL (7.0 mmol/L) or random blood glucose ≥200 mg/dL (11.1 mmol/L), or uses oral or injectable antihyperglycemic medications.
    • Patients with any endocrinopathy, or patient has abnormal TSH at screening
    • Patients with marked hypertriglyceridemia (fasting triglycerides >600 mg/dL [6.8 mmol/L]).
    • Patients with significant cardiovascular disease, active liver disease or a history of chronic liver disease, significant pulmonary disease, significant gastrointestinal disease, significant renal disease or a history of neoplastic disease.
    • Patients who are HIV positive as determined by medical history.
    • Patients who are pregnant or lactating woman, or plan to become pregnant.
    • Patients who have undergone surgical treatment for obesity.
    • Patients with clinically significant abnormalities of laboratory safety tests including :Serum creatinine >1.5 times Upper Limit of Normal (ULN) (>2.1 mg/dL), Serum ALT and/or AST >2 times the ULN(ALT >50 mU/mL; AST >44 mU/mL) and hemoglobin <12.5 gm/dL [7.76 mmol/L] in men and <11.0 gm/dL [6.83 mmol/L] in women.
    • Patients with viral hepatitis (hepatitis B or C).
    • Patients currently uses, or has used within 3 months prior to Visit 1 (Week-3), or plans to use, any prescription or nonprescrition drugs, including over the counter or herbal preparations (e.g , St. John´s Wort), that can alter body weight.
    • Patient treated with fenfluramine, dexfenfluramine either alone or in combination with any other medication at any time.
    • Patients who use or are likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP 3A4 or who consume more than 1 quart (four 8 oz. glasses) of grapefruit juice per day at any time during the study..
    • Patients with a history of substance abuse within the past 5 years.
    • Patients who smoke cigarettes or used nicotine-containing products
    • Patients who participated in a weight loss program involving pharmacologic treatment or dietary intervention during the 3 months prior to study start or intend to be involved in any such effort.
    • Patients with clinically significant abnormalities of prestudy electrocardiogram, including but not limited to, prolonged QTc.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variables are body weight at Week 52. The primary efficacy variable of body weight consists of 3 endpoints: change from baseline at Week 52, proportion of patients who lose ≥5% of their baseline body weight (5% responders) and proportion of patients who lose ≥10% of their baseline body weight (10% responders) at Week 52.
    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 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 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) 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 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.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 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 2005-06-22. 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 state720
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1080
    F.4.2.2In the whole clinical trial 2420
    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 Decision2005-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-02
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