Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36059   clinical trials with a EudraCT protocol, of which   5925   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2004-000280-99
    Sponsor's Protocol Code Number:201
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-18
    Trial 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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2004-000280-99
    A.3Full title of the trial
    A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Dose-Titration Study of Imidapril Hydrochloride (EG006) in the Treatment of Cancer Cachexia
    A.4.1Sponsor's protocol code number201
    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 SponsorArk Therapeutics, Ltd.
    B.1.3.4CountryUnited Kingdom
    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.2.1.1.1Trade name Tanatril
    D.2.1.1.2Name of the Marketing Authorisation holderTanabe Europe NV
    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 nameImidapril hydrochloride
    D.3.2Product code EG006
    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 INNImidapril
    D.3.9.3Other descriptive name(4S)-3-[(2S)-2-[(1S)-N-(1-Ethoxycarbonyl-3-phenylpropyl)amino]-propionyl]-1-methyl-2-oxoimidazolidin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number1.67
    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 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.2.1.1.1Trade name Tanatril
    D.2.1.1.2Name of the Marketing Authorisation holderTanabe Europe NV
    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 nameImidapril hydrochloride
    D.3.2Product code EG006
    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 INNImidapril
    D.3.9.3Other descriptive name(4S)-3-[(2S)-2-[(1S)-N-(1-Ethoxycarbonyl-3-phenylpropyl)amino]-propionyl]-1-methyl-2-oxoimidazolidin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number3.33
    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 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
    Cancer Cachexia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Level PT
    E.1.2Classification code 10006895
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of this trial is to evaluate the efficacy of oral imidapril hydrochloride (imidapril) compared to placebo in the treatment of weight loss in patients with advanced cancer or recurrent cancer
    E.2.2Secondary objectives of the trial
    To assess the effects of oral imidapril compared to placebo on changes in body composition, muscle strength, fatigue, appetite, and health status. Also to evaluate the safety of oral imidapril in the treatment of patients with advanced cancer or recurrent cancer.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female patients >18 years of age. Female patients of childbearing potential must be using an acceptable method of contraception.
    2. Patients with non-small cell lung cancer, colorectal adenocarcinoma or pancreatic cancer who have been diagnosed with advanced (unresectable) or recurrent illness.
    3. Patients with unintentional and undesired weight loss, defined as loss of at least 5% of body weight within the previous 6 months, documented where possible.
    4. Patients who are either a) not expected to undergo any chemotherapy during the study or b) who are commencing first line chemotherapy for metastatic or recurrent disease
    5. Patients with life expectancy of >3 months.
    6. Patients with Karnofsky performance score of >60.
    7. Patients who provide written informed consent.
    E.4Principal exclusion criteria
    1. Patients with abnormal uncorrected thyroid status at the screening visit defined as serum TSH or free T4 values outside the normal range
    2. Patients receiving parenteral nutrition or enteral hyperalimentation (patients with percutaneous endoscopic gastrostomy [PEG] feeding that is not for the purpose of hyperalimentation can enter study, provided that study medication tablets can be administered whole)
    3. Patients diagnosed with a Diagnostic and Statistical Manual (DSM)-classified eating disorder such as anorexia nervosa or bulimia
    4. Patients with low blood pressure defined as a sitting systolic blood pressure less than 100 mmHg at screening or baseline visits or with hypotension defined as grade 2 or greater according to the National Cancer Institute Common Toxicity Criteria [NCI-CTC, version 2.0]
    5. Patients with a history of clinical symptoms of postural hypotension such as dizziness within the last 6 months
    6. Patients with orthostatic changes in blood pressure, defined as a decrease in systolic blood pressure of greater than 20 mmHg or decrease in diastolic blood pressure of greater than 10 mmHg after shifting from a supine to sitting (with legs dependent) position at screening or baseline visits
    7. Patients with an active, acute infection
    8. Patients with a history of angioneurotic edema
    9. Patients with ascites, generalized edema, or pleural effusion requiring treatment or likely to require treatment during the study
    10. Patients with renal disease (serum creatinine of >2 mg/dL or >180 umol/L); or severe hepatic dysfunction (ie, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin levels at toxicity grade 3 or 4 (according to the NCI-CTC criteria, version 2.0) at the screening visit
    11. Patients with hyperkalemia, defined as grade 3 or 4 according to the NCI-CTC, version 2.0 (> 6.0mmol/L) at the screening visit
    12. Patients with total white blood cell counts of <1500/uL at the screening visit
    13. Patients who are concomitantly receiving any of the following during the course of the study: investigational drugs (other than the study medication), potassium-sparing diuretics, lithium, megestrol, an anabolic regimen (eg, oxandralone, testosterone, or growth hormone); ProsureTM, cyproheptadine hydrochloride, pentoxifylline, thalidomide; cannabinoids eg. dronabinol (Marinol); angiotensin II antagonist; angiotensin converting enzyme (ACE) inhibitor other than the study medication; tumor necrosis factor-alpha(TNF-alpha) antagonist; interleukin (IL)-1 antagonist; IL-2; or interferon.
    14. Patients who have been treated with systemic steroids for more than 21 consecutive days within the previous 3 months prior to initiation of study medication.
    15. Patients who will receive concomitant systemic steroids during the study, except for the treatment of chemotherapy side effects (eg, nausea, vomiting, joint pain, etc) for a maximum of 1 week per chemotherapy cycle during the course of the study
    16. Patients who are receiving or are planned to receive upper abdominal radiotherapy or cranial radiotherapy
    17. Patients who were treated with any investigational drug within 30 days or within 5 plasma half-lives (whichever is the longer) prior to the initiation of study medication.
    18. Patients who have known hypersensitivity to ACE inhibitors.
    19. Patients who are not capable of fully understanding the study requirements or are unwilling/ unable to comply with the study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) 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 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.8.5The 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 months4
    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.1.3Elderly (>=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 2004-08-18. 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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 160
    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 Decision2005-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA