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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:2007-005721-30
    Sponsor's Protocol Code Number:161HF201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-21
    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 number2007-005721-30
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients with Heart Failure and Renal Insufficiency
    A.3.2Name or abbreviated title of the trial where available
    POSEIDON
    A.4.1Sponsor's protocol code number161HF201
    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 SponsorBiogen Idec Limited
    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 No
    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 nameAdentri
    D.3.2Product code Tonapofylline
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 340021-17-2
    D.3.9.2Current sponsor codeTonapofylline
    D.3.9.3Other descriptive nameAdentri
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 No
    D.3.11.8Extractive medicinal product No
    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 No
    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 nameAdentri
    D.3.2Product code Tonapofylline
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 340021-17-2
    D.3.9.2Current sponsor codeTonapofylline
    D.3.9.3Other descriptive nameAdentri
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    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 No
    D.3.11.8Extractive medicinal product No
    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, hard
    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
    Heart Failure and Renal Insufficiency.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038474
    E.1.2Term Renal insufficiency
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    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 objective of this study is to assess the safety and tolerability of Tonapofylline administered to subjects with heart failure and renal insufficiency
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the effect of Tonapofylline on the following in subjects with heart failure and renal insufficiency:
    • Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Exercise capacity as measured by 6-minute walk distance
    • Renal function as assessed by serum creatinine and Cystatin-C
    • Concomitant medications used to treat heart failure
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    EXPLORATORY GENETIC TESTING SUB-STUDY IN ASSOCIATION WITH STUDY 161HF201 (OPTIONAL)
    The goal of the planned exploratory genetic analysis in this study is to gather data that may lead to the identification of genetic factors that may affect the safety and efficacy of Tonapofylline.

    BIOMARKER ANALYSIS SUB-STUDY IN ASSOCIATION WITH STUDY 161HF201 (OPTIONAL)
    Serum samples collected during the study may be used for proteomic analysis. Proteomic measurements may be broad-based or targeted to drug (Tonapofylline)pathway- or disease (heart failure and/or renal deficiency) pathway-related proteins.
    E.3Principal inclusion criteria
    1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
    2. Must be 18 years of age or older.
    3. Must have a previous diagnosis of HF with symptoms of HF present at screening (i.e., subjects must be graded as NYHA Class II, III, or IV).
    4. Must meet the following criteria (subjects graded as NYHA Class III or IV at screening must meet one of the following, while subjects graded as NYHA Class II at screening must meet both of the following):
    • history of hospitalization for HF >1 month and ≤12 months prior to the screening
    visit, or documented, unscheduled outpatient treatment with intravenous (IV)
    diuretics, IV vasodilators, or IV inotropic medications >1 month and ≤12 months
    prior to the screening visit
    • documented BNP ≥150 pg/mL, or NTproBNP ≥500 pg/mL, within the 12 months
    prior to Day 1.
    5. Must have renal insufficiency as defined by a reduced estimated glomerular filtration rate (eGFR) at the time of screening ≥20 and ≤70 mL/min/1.73 m2, as determined by the Modification of Diet in Renal Disease (MDRD) equation (abbreviated version).
    6. Must be on an oral loop diuretic for at least the 4 weeks prior to Day 1. Dose
    adjustments are allowed within the 4 weeks prior to Day 1, but the dose on Day 1 must be within 50% to 200% of the dose the subject was receiving at 4 weeks prior to Day 1.
    The introduction or withdrawal of any other class of diuretic (i.e., thiazide diuretics) is
    not allowed within the 4 weeks prior to Day 1
    7. Subjects with a reduced LVEF (≤40%) documented during screening must be on a
    pharmacological treatment regimen for HF for at least the 4 weeks prior to Day 1. The
    HF regimen must include:
    • treatment with a beta-blocker, unless contraindicated due to intolerance, and
    • treatment with an angiotensin converting enzyme (ACE) inhibitor or angiotensin
    receptor blocker (ARB), unless contraindicated due to intolerance.
    Note: The dose of any of the HF medications listed above may be adjusted once within the 4 weeks prior to Day 1. This restriction also applies to subjects with LVEF >40% if they are receiving treatment with beta-blockers, ACE inhibitors, and/or ARBs.
    8. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 2 months after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3. All female subjects of childbearing potential must have a negative pregnancy test on Screening Day and Day 1.
    E.4Principal exclusion criteria
    1. History of an allergic reaction to any xanthine-containing compound.
    2. History of seizure within the past 10 years or use of any medication for the suppression of seizures within the past 5 years.
    3. Within the past 2 years, history of head injury with loss of consciousness, stroke, or transient ischemic attack.
    4. History of multiple sclerosis, Alzheimer’s disease, mental retardation,
    meningitis/encephalitis, brain surgery, or penetrating head trauma.
    5. History of, or prior neuroimaging evidence of, intracranial pathology known to increase the risk of seizure such as brain tumors of any kind (including meningioma),
    arteriovenous malformation, cerebral cavernous malformation, hydrocephalus, or
    encephalomalacia.
    6. History consistent with illicit use of drugs or alcohol abuse within 6 months prior to
    Day 1.
    7. Hospitalization for HF within 30 days of Day 1.
    8. Myocardial infarction (MI) within 30 days of Day 1.
    9. Hemodynamically destabilizing arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation) within 30 days of Day 1.
    10. Cardiac surgery within 60 days prior to Day 1.
    11. Uncorrected hemodynamically significant primary valvular disease.
    12. Known obstructive or restrictive cardiomyopathy.
    13. Currently receiving chronic renal replacement therapy (e.g., hemodialysis or peritoneal dialysis).
    14. Receiving adenosine or xanthine-based agents (e.g., aminophylline, theophylline,
    pentoxifylline, or dyphylline).
    15. Receiving clozapine or metronidazole within 5 days of screening, during the screening period, or anticipated use during study drug treatment.
    16. Regular consumption of excessive amounts of caffeinated beverages (e.g., >72 ounces [2.13 liters or 9 cups] of coffee/day).
    17. Initiation of cardiac resynchronization treatment within 30 days prior to Day 1.
    18. Serious systemic infection (e.g., septicemia) or major surgical procedures within the 30 days prior to Day 1.
    19. Fever, with body temperature >38oC, within the 48 hours prior to first dose.
    20. Evidence of malignancy within 6 months prior to Day 1. Subjects with a history of
    stable prostate cancer, basal cell carcinomas, or fewer than 3 squamous cell carcinomas are eligible.
    21. Likelihood, in the Investigator’s opinion, of undergoing cardiac transplantation, left ventricular assist device (LVAD) or other device implantation, or other cardiac surgerywithin next 3 months; or of requiring continuous IV inotropic treatment, or referral for hospice or end of life treatment.
    22. Sustained systolic blood pressure >170 or <90 mmHg at Screening Day or Day 1.
    23. Screening laboratory findings as follows (Screening laboratory tests should be
    performed at the central laboratory):
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times the
    upper limit of normal, or
    • Total bilirubin >2.0 mg/dL.
    24. Nursing mothers, pregnant women, or women planning on becoming pregnant during
    the study.
    25. Participation in any other investigational study of drugs or devices within 30 days prior
    to Day 1.
    26. Unwillingness to comply with protocol-required procedures.
    27. Presence of any clinically significant (as determined by the Investigator)
    endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
    neurologic, dermatologic, psychiatric, and/or other major disease that might interfere
    with optimal safe participation in this study.
    28. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The safety and tolerability of Tonapofylline administered to subjects with stable heart failure and renal insufficiency. This objective will be evaluated by the incidence of AEs and SAEs, clinically abnormal physical examinations and vital signs, shifts to outside the normal ranges in laboratory parameters, and electrocardiogram results.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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 Patient Last Visit
    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 months5
    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 months8
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 300
    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)
    Subjects will revert to standard care after their participation in the trial has ended
    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 Decision2009-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-12-14
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