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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
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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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.
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    EudraCT Number:2008-008384-10
    Sponsor's Protocol Code Number:NIL-CDNP-CT005
    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:2009-03-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2008-008384-10
    A.3Full title of the trial
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNIL-CDNP-CT005
    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 SponsorNile Therapeutics, 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.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 nameChimeric natriuretic peptide - CDNP
    D.3.2Product code CD-NP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCD-NP
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Decompensated Heart Failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064653
    E.1.2Term Acute decompensated 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
    To assess the safety and tolerability of CD-NP infusion
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess efficacy of CD-NP on improvement of clinical symptoms and major adverse cardiac and renal events, to explore dose relationship of CD-NP on biomarkers such as creatinine, Cystatin-C, NGAL, KIM1, and to explore relationship of CD-NP use to urine volume output, hospital readmission and medication intensification.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be between 18 and 85 years of age, inclusive.
    2. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg and diastolic blood pressure ≥ 60 mmHg and ≤ 110 mmHg at the time of screening.
    3. Hospitalized for ADHF (decompensated chronic HF or acute HF). Patients who develop ADHF while hospitalized for another reason are not eligible.
    4. The underlying primary etiology for ADHF should be cardiac rather than pulmonary disease. For this study, ADHF requires all of the following at the time of screening:
    a. Dyspnea at rest (sitting or supine) or with minimal exertion (such as, talking, eating, etc.);
    b. Pulmonary congestion on chest radiograph (X-ray) or on physical examination; and
    c. BNP ≥ 300 pg/mL or NT-pro-BNP ≥ 1200 pg/mL.
    5. Compromised renal function defined as CrCL from 30 to 89 mL/min (as estimated by either Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) Study
    6. Able to begin study drug infusion within 24 hours from presentation to the hospital, including time spent in the emergency department.
    7. Female patients must be post-menopausal or surgically sterile. A woman may be considered to be surgically sterilized if she has had a bilateral tubal ligation (for at least 6 months), bilateral oopherectomy or complete hysterectomy.
    8. Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.

    The following criteria must continue to be met prior to study drug initiation:
    1. Systolic blood pressure ≥ 115 mmHg and ≤ 200 mmHg and DBP ≥ 60 mmHg and ≤ 110 mmHg.
    2. Has not received IV bolus dose of furosemide or equivalent loop diuretic including doses administered in the ambulance or emergency department, in excess of the following:
    - 40 mg within 6 hours prior to study drug initiation
    - 80 mg within 8 hours prior to study drug initiation
    - 100 mg within 10 hours prior to study drug initiation
    3. Has not received IV bolus dose of furosemide or equivalent loop diuretic within 2 hours prior to study drug initiation.
    4. If receiving continuous IV infusion of diuretics or nitrates, the dose has not been up-titrated within 2 hours prior to dosing.
    5. No morphine administration within 2 hours prior to dosing and able to withhold morphine administration for the first 6 hours after study drug initiation.
    E.4Principal exclusion criteria
    1. Acute or suspected acute myocardial infarction (AMI) or troponin levels > 5X3X the upper limit of normal at the institution’s local laboratory.
    2. Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening.
    3. Current or planned treatment with any of the following therapies prior to study drug initiation:
    a. IV infusion of nesiritide, inotropic agents or vasopressors.
    b. Received or planned to receive IV bolus dose(s) of furosemide or equivalent loop diuretic including doses administered in the ambulance or emergency
    department, in excess of the following:
    - 40 mg within 6 hours prior to study drug initiation
    - 80 mg within 8 hours prior to study drug initiation
    - 100 mg within 10 hours prior to study drug initiationin excess of 40 mg as a single dose
    c. mechanical support (such as, intra-aortic balloon pumps, mechanical ventilation, or any ventricular assist device).
    d. continuous positive positive airway pressure (CPAP).
    e. intubation.
    4. Cardiogenic shock.
    5. Evidence of uncorrected volume depletion
    6. Hyponatremia defined as serum Na ≤ 130 mEq/L.
    7. Clinically significant aortic or mitral valve stenosis.
    8. Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment.
    9. ADHF due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or atrial fibrillation/flutter with ventricular response of > 160 beats per minute).
    10. Severe renal failure defined as creatinine clearance < 30 mL/min as estimated by
    both the Cockcroft-Gault estimation and the MDRD equations
    11. Current or planned ultrafiltration, hemofiltration, or dialysis.
    12. Significant pulmonary disease (history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids).
    13. Any organ transplant recipient, currently listed (anticipated in the next 60 days) for transplant, or admitted for cardiac transplantation.
    14. Major surgery within 30 days.
    15. Major neurologic event, including cerebrovascular events in the prior 60 days.
    16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns).
    17. Known hepatic impairment as indicated by any of the following:(total bilirubin > 3 mg/dL, albumin < 2.8 mg/dL, with other signs or symptoms of hepatic dysfunction or increased ammonia levels, if performed with other signs or symptoms of hepatic dysfunction ).
    18. Received an investigational drug within 30 days prior to screening.
    19. Women who are pregnant or breastfeeding.
    20. Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds.
    21. Any condition which could interfere with, or for which the treatment might interfere with the conduct of the study, or which would unacceptably increase the risk of the patient's participation in the study. This may include, but is not limited to alcoholism, drug dependency or abuse, psychiatric disease, epilepsy, or any unexplained blackouts.
    22. Patients diagnosed with Chagas’ cardiomyopathy.
    23. Administration of IV contrast agent within the past 48 hours
    24. Known predisposition to excessive vasodilatation in response to blood pressure lowering medications.
    E.5 End points
    E.5.1Primary end point(s)
    Key safety endpoints will include:
    · The occurrence of symptomatic hypotension from start of study drug to within 6 hours after discontinuation of study drug
    · The occurrence of either of the following from start of study drug to within 6 hours after discontinuation of study drug:
    o a decrease in systolic blood pressure of at least 20 mm Hg to < 90 mmHg, or
    o symptomatic hypotension.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned5
    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 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
    The end of the trial is defined by the last visit of the last subject, which occurs 30 to 33 days following the initiation of study drug infusion.
    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 months1
    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 months1
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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 20
    F.4.2.2In the whole clinical trial 75
    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)
    Standard medical treatment
    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 Decision2009-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-10-14
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