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    Summary
    EudraCT Number:2015-004275-70
    Sponsor's Protocol Code Number:GPD-01-01
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-12-18
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2015-004275-70
    A.3Full title of the trial
    Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study.
    Influência dos polimorfismos de nucleótido único do gene da carboxipeptidase D (CPD) na redução do peso corporal e massa gorda com Perindopril em doentes obesos: um estudo de Fase II, multicêntrico, de dupla ocultação
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of single nucleotide polymorphisms of carboxypeptidase D (CPD) gene on body weight and fat mass reduction by perindopril in obese subjects: A phase II, multicenter, double-blind study.
    Influência dos polimorfismos de nucleótido único do gene da carboxipeptidase D (CPD) na redução do peso corporal e massa gorda com Perindopril em doentes obesos: um estudo de Fase II, multicêntrico, de dupla ocultação
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    Nao aplicavel
    A.4.1Sponsor's protocol code numberGPD-01-01
    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 SponsorGene PreDiT SA
    B.1.3.4CountryPortugal
    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 supportGene PreDiT SA
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBlueclinical - Investigacao e Desenvolvimento em Saude, Lda
    B.5.2Functional name of contact pointBlueclinical
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Villagarcia de Arosa, nº1919, 1º
    B.5.3.2Town/ cityPorto
    B.5.3.3Post code4460-439
    B.5.3.4CountryPortugal
    B.5.4Telephone number00351220 995 159
    B.5.5Fax number00351223 200 699
    B.5.6E-maillalmeida@blueclinical.pt
    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 Perindopril Bluepharma
    D.2.1.1.2Name of the Marketing Authorisation holderBluepharma Genéricos - Comercio de Medicamentos SA
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 namePerindopril Bluepharma
    D.3.2Product code Not applicable. Trade name provided above
    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 INNPERINDOPRIL
    D.3.9.3Other descriptive namePERINDOPRIL
    D.3.9.4EV Substance CodeSUB09730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    Body weight and fat mass reduction by perindopril in obese subjects
    E.1.1.1Medical condition in easily understood language
    Body weight and fat mass reduction by perindopril in obese subjects
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    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
    To evaluate CPD genotyping as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated with perindopril.
    E.2.2Secondary objectives of the trial
    To assess the association between CPD genotypes/single nucleotide polymorphisms (SNPs) and response to perindopril.
    To evaluate the effect of perindopril in waist circumference, waist/hip ratio, and BMI.
    To evaluate the tolerability and safety of perindopril in the study population.
    To evaluate CPD genotyping as a predictive biomarker of body weight and/or fat mass reduction as per regulatory requirements in obese patients treated with perindopril.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent;
    Man or woman with 18 years or more;
    Body Mass Index (BMI) between 30.0 to 40.0 kg/m2;
    Willingness and ability to comply with the study requirements;
    Ability to understand and sign informed consent;
    If woman of childbearing potential, she agrees to adopt an effective contraceptive method.
    E.4Principal exclusion criteria
    Pregnant or breastfeeding women;
    History of obesity with a known cause (e.g., hypothyroidism, Cushing's disease);
    Under treatment with perindopril or other angiotensin converting enzyme (ACE) inhibitor, or with an angiotensin receptor blocker (ARB) or a renin inhibitor;
    Hypertension diagnosed at screening;
    Significant variation in weight (>10%) in the past 3 months before screening visit;
    History of anorexia nervosa, bulimia, or binge-eating disorder;
    Systolic blood pressure <110 mmHg;
    History of hypersensitivity to perindopril, or other ACE inhibitors, or to any of the inactive ingredients;
    History of angioedema associated with previous ACE inhibitor therapy;
    History of idiopathic or hereditary angioedema;
    Treatment with concomitant medication affecting weight loss (e.g. metformin) starting within the 3 months prior to screening;
    Treatment with concomitant medication that might interfere with the absorption, distribution, metabolism or elimination of perindopril, or, is likely to compromise the safety of subject (e.g. diuretics in patients with salt and/or volume depletion, insulin or oral antidiabetics in patients prone to develop hypoglycemic episodes, lithium, vasodilators in patients prone to develop hypotension, tricyclic antidepressants, antipsychotics, anesthetics, gold, potassium supplements or potassium-containing salt substitutes);
    Treatment with any investigational drug or device within 1 month before the start of the run-in period;
    Moderate to severe hepatic impairment (Child-Pugh score ≥ 7) or moderate to severe renal impairment (glomerular filtration rate (GFR) ≤ 59 ml/min);
    Unstable coronary artery disease;
    Aortic and mitral valve stenosis / hypertrophic cardiomyopathy
    Hemodialysis patients;
    Kidney transplantation;
    Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis;
    Neutropenia/agranulocytosis/thrombocytopenia/Anemia;
    Patients undergoing major surgery or during anesthesia with agents that produce hypotension;
    Hyperkalemia;
    Any other condition or therapy that the study physician considers to make the subject unsuitable for this study.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate, defined as the proportion of patients who will lose at least 3% of body weight and/or at least 3% of fat mass from end of the run-in period to the end of the perindopril treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Body weight, body mass index (BMI), waist and hip circumference, and body fat mass estimation will be assessed at every study visit: 6 weeks after period 2 initiation and the the end of period 2
    E.5.2Secondary end point(s)
    End vs start of treatment relative change in body weight.
    End vs start of treatment relative change in fat mass.
    End vs start of treatment relative change in waist circumference.
    End vs start of treatment relative change in hip circumference.
    End vs start of treatment relative change in fasting lipid profile.
    Frequency and type of adverse events.
    Response rate, defined as the proportion of patients who will lose at least 5% of body weight and/or at least 5% of fat mass from end of the run-in period to the end of the perindopril treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Body weight, body mass index (BMI), waist and hip circumference, and body fat mass estimation will be assessed at every study visit: 6 weeks after period 2 initiation and the the end of period 2
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned11
    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
    LVLS
    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 months
    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: 120
    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 state160
    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)
    None. Not applicable.
    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 Decision2015-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-28
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