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    Summary
    EudraCT Number:2005-000464-95
    Sponsor's Protocol Code Number:IPC-05-2004
    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:2005-08-24
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-000464-95
    A.3Full title of the trial
    A phase II randomized, double-blind, placebo-controlled, multi-center study to evaluate tolerability, safety pharmacokinetics and efficacy of intravenous INO-1001 in high-risk subjects undergoing cardiopulmonary by-pass for coronary revascularization and/or valve surgery.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberIPC-05-2004
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    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 SponsorInotek Pharmaceuticals Corporation
    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 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 nameINO-1001
    D.3.2Product code NA
    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 use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN9-[N- (3-morpholinopropyl)-aminosulfonyl]-5,6-dihydro-5-oxo-11-H-indeno [1,2-c] isoquinoline methanesulfonic acid
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeINO-1001
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125 mg/250 ml
    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 Information not present in EudraCT
    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.2.5The 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 nameINO-1001
    D.3.2Product code NA
    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 use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN9-[N- (3-morpholinopropyl)-aminosulfonyl]-5,6-dihydro-5-oxo-11-H-indeno [1,2-c] isoquinoline methanesulfonic acid
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeINO-1001
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250 mg/250 ml
    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 Information not present in EudraCT
    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 placeboIntravenous infusion
    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
    INO-1001 is being developed for the treatment of high-risk subjects undergoing cardiopulmonary bypass (CPB) for coronary revascularization and/or valve surgery.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that intravenous INO-1001 is safe and tolerable when administered to subjects undergoing elective CPB for coronary revascularization and/or valve surgery.

    To demonstrate that INO-1001 reduces a composite endpoint of major post-operative complications during the first 30 post-operative days in high-risk subjects undergoing elective CPB for coronary revascularization and/or valve surgery.
    E.2.2Secondary objectives of the trial
    To demonstrate that INO-1001 improves post-operative clinical outcomes and physiologic parameters during the first 30 post-operative days in high risk subjects undergoing elective CPB for coronary revascularization and/or valve surgery.

    Assessment of the pharmacokinetic profile of intravenous INO-1001 administered to subjects undergoing elective CPB for coronary revascularization and/or valve surgery.

    Assessment of the effect of intravenous INO-1001 on cardiac biomarkers in subjects undergoing elective CPB for coronary revascularization and/or valve surgery.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    All eligible subjects must meet all of the following criteria:
    • Scheduled to undergo elective cardiopulmonary bypass for coronary revascularization and/or valve surgery
    • Written informed consent must be obtained prior to participation
    • Age eighteen (18) to ninety (90) years (inclusive)
    • Males and non-pregnant non-lactating femals of child-bearing potential who agree to use two effective methods of contraception (e.g. condom and spermicide) for three (3) months following exposure to the study drug.
    • Third (Main) Phase ONLY: European System for Cardiac Operative Risk Evaluation (euroSCORE) equal to or greater than six calculated at any time within ninety-six hours prior to anticipated study drug administration.
    E.4Principal exclusion criteria
    To be eligible for entry into the study, subjects must not have any of the following criteria:
    • History of a hypersensitivity reaction to more than three drugs or to mannitol
    • Participation in any other investigational study within thirty (30) days of the Screening Phase
    • Myocardial infarction within seventy-two (72) hours of the study drug infusion
    • Clinically significant abnormalities in any clinical laboratory tests, as judged by a Clinical Investigator
    • Clinically significant hematological, hepatic, renal, pulmonary, or gastrointestinal disorder, as judged by a Clinical Investigator
    • Any known malignancy other than treated basal cell skin cancer or cervical carcinoma in situ
    • Dialysis, creatinine > 2 mg/dl, or ALT or AST above the upper limits of normal
    • History of Hepatitis B, Hepatitis C, acute or chronic hepatitis, or history / demonstration of HIV antibodies or AIDS
    • Female subjects who are currently pregnant, lactating, or have a positive pregnancy test
    • Any recent (acute) or chronic medical, psychological or social issue that in the opinion of the investigator might interfere with the performance, completion, or interpretation of this study
    • Subjects who have received an irreversible CYP3A4 inhibitor orally or parenterally within approximately three (3) days of study drug administration, including azole antifungals (e.g. ketoconazole, itraconazole, miconazole, fluconazole); macrolide antibiotics (e.g. clarithromycin, erythromycin, troleandomycin; but not azithromycin); HIV-related protease inhibitors (e.g. Crixivan [Indinavir], Invirase [saquinavir], Norvir [ritonavir], and Viracept [nelfinavir]); the anti-depressant nefazodone; and the long-acting benzodiazepines (e.g. diazepam).
    • Subjects who have received the potent irreversible CYP3A4 inhibitors verapamil or diltiazem within approximately seven (7) days of study drug administration.
    • Subjects who have received amiodarone within thirty (30) days of the study drug administration
    • Subjects with repeated demonstration of a QTc intervals > 450 msecs or known Long QT Syndrome
    • Known alcohol or drug abuse within the last year
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be a reduction in a composite endpoint consisting of any one of the following major post-operative complications which occur during the Treatment, Observation, or Followed-Up Phases:
    • thirty day all-cause mortality
    • prolonged mechanical ventilation, as defined by mechanical ventilatory support > seventy-two hours following arrival in the intensive care unit / recovery room
    • renal dysfunction, as defined by a need for renal replacement therapy (dialysis or CVVH)
    • profound cardiac failure, as defined by requirement of a left ventricular assist device or prolonged use of intravenous vasopressors or inotropic agents, as defined by usage more than forty-eight (48) hours following arrival in the intensive care unit / recovery room
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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
    The Follow-Up Phase on Day 30, is considered as the end of trial.
    A subject may withdrawn from the study under the following conditions:
    a. Subject withdraws consent
    b. Subject compliance to the protocol is poor
    c. Any condition that in the physician's opinion may cause risk to the subject. In this case, the Investigator should specify on the CRF the reason for subject's withdrawal.
    In all cases of early subject withdrawal all study termination procedures should be followed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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 months12
    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 2005-08-24. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 162
    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)
    No specific treatment that is different from the treatment expected for that condition is planned.
    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 Decision2005-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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