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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2008-002209-38
    Sponsor's Protocol Code Number:7418-503
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-07-23
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-002209-38
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled study of the hemodynamic effects of rolofylline injectable emulsion in the treatment of patients with heart failure
    A.4.1Sponsor's protocol code number7418-503
    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 SponsorNovaCardia, Inc. (A wholly owned subsidiary of Merck & Co., Inc.)
    B.1.3.4CountryUnited States
    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 nameRolofylline Injectable Emulsion
    D.3.2Product code MK-7418/KW-3902
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 136199-02-5
    D.3.9.2Current sponsor codeMK-7418/KW-3902
    D.3.9.3Other descriptive nameRolofylline
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients hospitalised with heart failure, volume overload and renal impairment, who require loop diuretic therapy and hemodynamic monitoring for clinical reasons
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute 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 objectives of this study are to estimate the effects of rolofylline, alone in addition to loop diuretic therapy, on pulmonary capillary wedge pressure, as well as other hemodynamic parameters, and to estimate the effects of rolofylline on diuresis and natriuresis in patients with heart failure and renal impairment.
    E.2.2Secondary objectives of the trial
    All adverse events will be monitored and reported during the study treatment period to determine safety. Adverse events (AEs) will be recorded after obtaining informed consent through Day 7. Serious Adverse Events (SAEs) will be recorded through Day 14. Physical examination, hemodynamic, and laboratory data will also be evaluated.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent
    2. Male or female 18 years of age or greater
    3. Current use of oral furosemide ≥80 mg/day or IV furosemide ≥40 mg/day (or equivalent dose of oral/IV loop diuretic)
    4. Stable heart failure therapy (excluding diuretics) for ≥24 hours prior to screening (treatment with ACE inhibitors, ARBS, digoxin, aldosterone blockers, nitrates, hydralazine, and other diuretics are allowed as long as doses are stable for at least 24 hours prior to screening)
    5. Impaired renal function defined as a creatinine clearance between 20-80 mL/min using the Cockcroft-Gault equation (corrected for height in edematous or obese patients ≥100 kg) based on serum creatinine measurements done within 24 hours of screening (13)
    6. BNP >500 pg/mL OR NT-pro-BNP >2000 pg/mL within 24 hours of screening
    7. Systolic blood pressure ≥95 mmHg (patients with a systolic blood pressure of 90 – 94 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within this range while clinically stable)
    8. Patients require at least 12 hours of hemodynamic monitoring in the period after screening.
    E.4Principal exclusion criteria
    9. Pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
    NOTE: Appropriate contraception (hormonal contraceptives [such as birth control pills, Depo-Provera, or contraceptive implants], condoms, diaphragms, spermicidal foam or jelly, surgical sterilization [hysterectomy or tubal ligation] or intrauterine device) should be used through Day 14.
    10. Acute contrast induced nephropathy
    11. Temperature >38°C (100.4 °F; oral or adjusted axillary/rectal temperature) or sepsis or active infection requiring IV anti-microbial treatment
    12. Administration of oral or IV loop diuretic within 3 hours prior to the initial screening
    13. Serum potassium <3.5 mEq/L
    14. Ongoing, recent (within 48 hours), or planned treatment with ultrafiltration, hemofiltration, or dialysis, or mechanical support (intra-aortic balloon pump, endotracheal intubation, ventricular assist device) during this hospitalization
    15. Rapidly progressive acute renal failure as manifested by an increase in SCr ≥0.7 mg/dL in a 24-hour period
    16. Evidence of acute tubular necrosis (urinary sediment, urinary sodium excretion, biopsy, etc.) or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure or its treatment (contrast media, cyclosporine, other nephrotoxins)
    17. Severe pulmonary disease (as evidenced by pre-admission or current oral steroid dependency, current treatment with IV steroids, or previous history of CO2 retention or intubation for acute exacerbation)
    18. Severe aortic or mitral stenosis or regurgitation
    19. Heart transplant recipient or admitted for imminent cardiac transplantation or LVAD surgery (i.e., expected within 72 hours)
    20. Any major surgery within 2 weeks prior to screening (cardiac or non-cardiac)
    21. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
    22. Significant arrhythmias (ventricular tachycardia, bradyarrhythmias with slow ventricular rate [<45 beats per minute] or atrial fibrillation/flutter with a rapid ventricular response of >120 beats per minute)
    23. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
    24. Known hepatic impairment with a total bilirubin >3 mg/dL, or an albumin <2.8 mg/dL, or increased ammonia levels (if available)
    25. BMI >35 kg/m2
    26. Hgb <8 g/dL or Hct <25% or the need for a blood transfusion
    27. Non-cardiac pulmonary edema, including suspected sepsis
    28. Administration of an investigational drug or device, or participation in another trial, within 30 days before randomization
    29. Current or anticipated therapy with atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
    30. Systolic blood pressure ≥160 mmHg at randomization
    31. Inability to follow instructions or comply with follow-up procedures
    32. Allergy to soybean oil, eggs, or benzodiazepines
    33. History of seizure (except febrile seizure)
    34. Stroke within 2 years
    35. History of or current brain tumor of any etiology
    36. Brain surgery within 2 years
    37. Encephalitis/meningitis within 2 years
    38. History of penetrating head trauma
    39. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
    40. History of drug or alcohol abuse or at risk for alcohol withdrawal seizures
    41. Advanced Alzheimer’s disease
    42. Advanced multiple sclerosis
    Baseline Period Exclusion Criteria (at least 1 hour prior to dosing):
    43. Balloon thermodilution catheter in place <3 hours
    44. PCWP ≤18 mmHg

    E.5 End points
    E.5.1Primary end point(s)
    Change in PCWP 4 and 8 hours after initiation of study drug.
    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 Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 66
    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 Decision2008-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-03-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 13:52:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA