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    Summary
    EudraCT Number:2009-015059-26
    Sponsor's Protocol Code Number:510460
    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:2010-07-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015059-26
    A.3Full title of the trial
    Efficacy of 12 weeks oral Pentalong® on Exercise Capacity and Quality of Life
    in Patients With Systolic Heart Failure and Secondary Pulmonary Hypertension
    Short title:
    CAESAR
    Clinical efficacy study of Pentalong® on Pulmonary Hypertension in Heart
    Failure
    (Actavis Trial Code (ATC)=510460)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of 12 weeks oral Pentalong® on Exercise Capacity and Quality of Life
    in Patients With Systolic Heart Failure and Secondary Pulmonary Hypertension
    A.3.2Name or abbreviated title of the trial where available
    CAESAR
    A.4.1Sponsor's protocol code number510460
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorActavis GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportActavis GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScientificMedicalServices
    B.5.2Functional name of contact pointProf. Dr. med. H. Theodor Schneider
    B.5.3 Address:
    B.5.3.1Street AddressBürkleinstr. 14 / HTS VI
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80538
    B.5.3.4CountryGermany
    B.5.4Telephone number004901776202026
    B.5.6E-mailprof.dr.h.t.schneider@gmx.de
    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 Yes
    D.2.1.1.1Trade name PENTALONG 80mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePENTALONG 80
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 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 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
    Woman and men suffering from heart failure NYHA II-IV and secondary pulmonary
    hypertension
    Objectives
    PVR improvement after a 12 week oral Pentalong® therapy in addition to standard long-term HF medication as well as improvement on exercise capacity (6MWD),
    quality of life (QOL-Questionaire), PAPsyst, LVEF, FS, TAPSE
    (echocardiography) at rest, PCWP, PAPs, PAPd, PAPm, RAP, RVSD, RVEDP (right
    heart catheter) at rest, biomarkers NTproBNP
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: Superiority in PVR improvement after a 12 week oral Pentalong®
    therapy in addition to standard long-term heart failure (HF) medication in patients suffering from HF
    E.2.2Secondary objectives of the trial
    Effects of Pentalong® therapy on exercise capacity (6MWD), quality of life (QOL Questionaire), PAPsyst, LVEF, FS, TAPSE (echocardiography) at rest, PCWP, PAPs, PAPd, PAPm, RAP, RVSD, RVEDP (right heart catheter) at rest, biomarkers NTproBNP (optional: Troponin-I, MR-proADM, CT-proET-1), optional Peak VO2 and VO2 at AT (CPET)

    Optional Analyses of the effects on the total genomic expression profiles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written Informed Consent before randomization
    - Men or women >18 and <80 years of age
    - Documented clinically systolic HF (NYHA II-IV) and secondary pulmonary
    hypertension
    - PAPm >30mmHg, PCW >15 mmHg, LVEF <45%, TPG normal or elevated
    - Ability of patient to understand the character and individual consequences of the
    clinical trial
    - For women with childbearing potential, adequate (Pearl Index <1) contraception. such as oral hormonal contraception (the pill), dermal hormonal contraception, vaginal hormonal contraception (NuvaRing), contraceptive patch, long-lasting injectable contraceptives, contraceptive coil, double barrier method)
    E.4Principal exclusion criteria
    - Cardiogenic shock
    - Acute circulatory failure
    - Acute decompensated heart failure (new occurrence of congestive signs)
    - Myocarditis
    - Implantation of CRT less than 12 months
    - Listed for HTx on high urgency status
    - Uncontrolled hypotension (systolic blood pressure <90 mmHg)
    - Uncontrolled Hypertension (systolic blood pressure >200mmHg)
    - Insufficient HF treatment not following ESC guidelines
    - Not on stable treatment for at least three months
    - Initiation of any of the following medications within the last 8 weeks: Aspirin,
    statins, calcium channel blockers, ACE-inhibitors or AT-1 receptor blockers,
    hormone replacement therapy.
    - Use of phosphodiesterase-5-inhibitors (Viagra®, Revatio®, Cialis®, Levitra®),
    dihydroergotamine and nitrates, i.e. isosorbidemononitrate, isosorbidedinitrate,
    nitroglycerin, pentaerithrityltetranitrate, or molsidomin within the last two weeks.
    - Treatment with hydralazin
    - Hemodynamically significant aortic or mitral stenosis or hypertrophic obstructive
    cardiomyopathy
    - Renal dysfunction (creatinine > 2.5 mg/dl)
    - Known hepatic disease (including hepatitis) or elevation of serum transaminases
    or GT > 5x ULN (upper limit of normal range)
    - Confirmed diagnosis of HIV infection
    - WBC >16.000 or platelet count >500.000/μl or <75.000/μl
    - Clinically overt hyperthyreodism
    - Suspected hyperthyreodism
    - Suspected Thyroid Carcinoma
    - Febrile illnesses
    - Known drug (alcohol) abuse
    - Pregnancy and lactation
    - Known intolerance to organic nitrates
    - History of hypersensitivity to the investigational medicinal product or to any drug
    with similar chemical structure or to any excipient present in the pharmaceutical
    form of the investigational medicinal product
    - X-ray contrast media allergy
    - Other significant laboratory abnormalities that the investigator feels may
    compromise the patient’s safety by participation in the study
    - Participation in other clinical trials and observation period of competing trials,
    respectively
    - Intoxication
    - Acute coronary syndrome
    - Missing informed consent
    No patient will be enrolled in this trial more than once.
    E.5 End points
    E.5.1Primary end point(s)
    PVR improvement after a 12 week oral Pentalong®
    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 No
    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 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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 concerned16
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months
    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 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 2010-07-01. Yes
    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 state100
    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 Decision2010-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-11
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