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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2004-001252-36
    Sponsor's Protocol Code Number:DM/PR/7401/009/03
    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:2005-06-01
    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 number2004-001252-36
    A.3Full title of the trial
    DOUBLE BLIND, PARALLEL GROUP, MULTICENTRE STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF CHF 1521 (FIXED COMBINATION OF MANIDIPINE AND DELAPRIL) VS LOSARTAN 50 MG AND HYDROCHLOROTHIAZIDE 12.5 MG IN TYPE 2 DIABETIC HYPERTENSIVE PATIENTS
    A.3.2Name or abbreviated title of the trial where available
    MORE
    A.4.1Sponsor's protocol code numberDM/PR/7401/009/03
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorChiesi Farmazeutici SpA
    B.1.3.4CountryItaly
    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.3.2Product code CHF 1521
    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 INNManidipine
    D.3.9.1CAS number 120092-68-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDelapril
    D.3.9.1CAS number 83435-66-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 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 nameHyzzar
    D.3.4Pharmaceutical form 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 INNLosartan
    D.3.9.1CAS number 114798-26-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHydrochlorothiazide
    D.3.9.1CAS number 58-93-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Essential Hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10015488
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the antihypertensive effects of a once daily fixed oral dose of CHF 1521 (delapril 30 mg and manidipine 10 mg, in combination), compared with once daily losartan 50 mg and hydrochlorothiazide 12.5 mg in combination, over a twelve week period, assessed by 24-h ambulatory blood pressure monitoring, in type 2 diabetic patients with mild to moderate essential hypertension .
    E.2.2Secondary objectives of the trial
    # To investigate the antihypertensive effects of CHF 1521 compared with losartan 50 mg and hydrochlorothiazide 12,5 mg, over a twelve week period. assessed in trought blood pressure.
    # To investigate the tolerability of CHF 1521 compared with losartan 50 mg and hydrochlorothiazide 12,5 mg, over a twelve week period, in type 2 diabetic patients with mild to moderate essential hypertension.
    # To investigate the effects on microalbuminuria of CHF 1521, compared with losartan 50 mg and hydrochlorothiazide 12,5 mg, over a twelve months period, in a subgroup of 120 type 2 diabetic patients with mild to moderate essential and with microalbuminuria at the inclusion (NOT IN GERMANY)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be included in this study, patients must satisfy the following criteria at the time points specified:

    At Visit 1 (Day -7):
    • Male or female > 45 years (females of child bearing potential must be using adequate contraceptive precautions)

    • Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at enrolment visit

    • Patients are attending an out-patient clinic visit

    • Type 2 diabetes controlled by diet and oral antidiabetic treatment (HbA1c < 7.5%).

    • Patients with mild to moderate uncomplicated essential hypertension with a trough mean sitting DBP >85 and <105 mmHg and SBP <160 mmHg

    • No evidence of significant cardiovascular disease other than hypertension in the opinion of the investigator

    • Written informed consent

    • Agreement to attend all study visits as planned in the protocol

    • Presence of persistent microalbuminuria (presence of urinary albumin-creatinine ratio: 2.5-25 mg/mmol for men and 3.5-25 mg/mmol for women, confirmed by at least one previous test in the last 3 months) for the patients to be included in the microalbuminuria sub-study.

    At Visit 2 (Day 0):
    • Mild to moderate hypertension, defined as a trough mean sitting DBP >85 and <105 mmHg and SBP <160 mmHg

    • 24-hour mean SBP > 130 mmHg (as measured by ABPM)

    • For the patients of the Microalbuminuria sub-study, presence of microalbuminuria (urinary albumin-creatinine ratio: 2.5-25 mg/mmol for men and 3.5-25 mg/mmol for women)
    E.4Principal exclusion criteria
    Patients will be excluded from the study if one or more of the following statements are applicable at enrolment visit:

    • In the investigator’s opinion the patient should not be withdrawn from their current antihypertensive medication

    • Malignant or secondary hypertension (e.g. patients with hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal disease, coarctation of the aorta, Cushing’s disease syndrome)

    • History of severe elevated blood pressure (mean sitting DBP >110 mmHg and/or SBP >160 mmHg

    • Orthostatic hypotension (difference between mean sitting and standing SBP >20 mmHg)

    • Obesity as defined by a Body Mass Index (BMI) > 32 Kg/m2

    • Chronic glaucoma treated with beta-blocker eye drops

    • Hypertensive retinopathy (Keith Wagener Barker [KWB] scale) grade 3 or 4

    • History of hypertensive encephalopathy or cerebrovascular accident

    • Presence of cardiac disease other than: uncomplicated hypertensive cardiovascular disease or a single uncomplicated myocardial infarction (MI), which occurred a minimum of twelve months before this study with stable ECG findings for a minimum of twelve months before this study

    • History of MI complicated by congestive heart failure or post-MI angina

    • Presence of any conduction arrhythmia including bradycardia (heart rate <45 beats per minute (bpm)), tachycardia (heart rate >100 bpm), ventricular arrhythmia

    • Presence of significant pulmonary, hepatic, renal, endocrine, metabolic or haematological disease, disorder, or dysfunction

    • Laboratory evidence of significant disease including the following**:
    - serum creatinine >1.5 mg/dl
    - serum potassium >10% x upper limit of normal (ULN)
    - aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN and/or total serum bilirubin >1.5 x ULN

    • Presence of gastrointestinal disease or history of gastrointestinal surgery which would interfere with drug absorption

    • History of significant allergies (including multiple drug allergies)

    • History of cancer including leukaemia and lymphoma within the past five years (skin cancer, other than melanoma, is an exception)

    • Diabetes mellitus requiring treatment with insulin

    • Uncontrolled diabetes (HbA1c > 7.5%)

    • Chronic use of any drug known to affect blood pressure such as: tricyclic antidepressants, monoamine oxidase inhibitors, neuroleptic drugs (any type), centrally acting antihypertensives (e.g. clonidine, methyldopa, guanfacin, moxonidine), reserpin, non-steroidal anti-inflammatory drug (NSAID) (acetylsalicylic acid [ASA] < 0.5 gram/day is allowed), oral or parenteral corticosteroids, antiarrhythmic drugs, digitalis and cardiac glycosides, amphetamine and its derivatives

    • Concomitant treatment with other antihypertensive drugs different from the study drugs (i.e. alpha receptor blockers and agonists, beta receptor blockers and agonists, calcium antagonists ACE inhibitors, angiotensin–II receptor antagonist and diuretics)

    • Concomitant use of lithium salts

    • Known allergy or a known intolerance to any calcium-antagonist or ACE-inhibitors or ARB or HCTZ.

    • Females who are pregnant or lactating

    • Use of any investigational drug within 28 days before the first dose of placebo medication

    • Patients previously enrolled into the study

    • History of drug, medications abuse.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the change from baseline (Day 0) to the end of the study (Day +84) in the 24-hour mean SBP, measured by ABPM.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months8
    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 months6
    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 2005-06-01. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 320
    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 Decision2005-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-17
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