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    Summary
    EudraCT Number:2008-007093-37
    Sponsor's Protocol Code Number:ACV20616
    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:2009-04-08
    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 number2008-007093-37
    A.3Full title of the trial
    Clinical efficacy of Pentalong® in stable Angina patients after 12 Weeks of routine administration:a randomised, double-blind, placebo-controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    CLEOPATRA
    A.4.1Sponsor's protocol code numberACV20616
    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 SponsorActavis Deutschland 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 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 Yes
    D.2.1.1.1Trade name Pentalong®
    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®
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNpentaerythritol tetranitrate
    D.3.9.1CAS number 78 11-5
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive namenot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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
    Stable, effort-induced angina pectoris
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10049194
    E.1.2Term Stable angina pectoris
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 trial is to show superiority of PETN over placebo in the treatment of patients with stable, effort-induced angina pectoris receiving anti-anginal background therapy in a modern, regulatory guideline compliant trial.
    E.2.2Secondary objectives of the trial
    A secondary objective is to evaluate the safety and tolerability of PETN 80 mg bid for treatment of adult subjects with stable, effort-induced angina pectoris.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At the end of the run-in period the following inclusion criteria must be fulfilled:
    1. Second qualifying ETT meeting all of the following criteria:
    - Positivity criteria: occurrence of limiting angina and ST-segment depression of at least 1 mm as compared to resting ECG, (horizontal or down sloping and persisting for at least 0.08 seconds after J-point, on at least three consecutive complexes) between 2.5 and 12 minutes of initiation with modified Bruce treadmill ergometer protocol. If the ETT is interrupted before reaching positivity for any reason, the patient will not be included.
    - Stability criteria: Difference between selection (Day -7) and inclusion (Day 0) ETT measurements has to be within 20% of the Day 0 value.
    2. At least 4 anginal attacks in the 4 week period preceding randomisation
    3. Compliance to treatment during the run-in period, i.e. placebo on top of background treatment (calculated compliance at least 85%, in addition, patient should not have missed more than one full daily dose).
    E.4Principal exclusion criteria
    Patients will not be included in the trial if one of the following criteria applies:
    General exclusion criteria:
    1. Incapability of understanding the language in which the information for the patient is given;
    2. Presence or history of drug or alcohol abuse;
    3. Presence of malignant disease in the past 5 years;
    4. The patient is a woman of childbearing potential who does not use a reliable
    method of contraception; (Note: A highly effective method of birth control is
    defined as those which result in a low failure rate (i.e. less than 1% per year)
    when used consistently and correctly such as implants, injectables,
    combined oral contraceptives, some IUDs, sexual abstinence or
    vasectomised partner);
    5. The patient is a pregnant or breast feeding woman;
    6. Participation in a concurrent clinical trial or in another trial within the past 4 weeks;
    7. Repeated participation in this trial;
    8. Anticipated poor medication compliance;
    9. The patient is the investigator him/herself.
    Trial-specific exclusion criteria:
    1. Recent acute myocardial infarction, coronary bypass surgery less than 3 months before inclusion or coronary angioplasty less than 6 months before inclusion;
    2. Unstable angina, Prinzmetal angina or microvascular angina;
    3. Angina pectoris symptoms typically induced by factors other than physical exertion;
    4. Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved;
    5. History of untreated, clinical relevant mitral insufficiency, constrictive
    pericarditis, pericardial tamponade, severe pulmonary hypertension, aortic
    stenosis, hypertrophic obstructive cardiomyopathy or other causes of left
    ventricular outflow tract obstruction. If such disorders are treated, the
    treatment should be confirmed by echocardiogram not older than 6 months.
    The clinical relevance of the disorders is left to the discretion of the
    investigator;
    6. Hyperresponsitivity or contraindications to nitrovasodilators in particular PETN and nitroglycerin;
    7. Anticipated elective percutaneous transluminal coronary angioplasty (PTCA) in the upcoming 12 weeks;
    8. Patient who cannot perform exercise tests, in particular for muscular, joint and/or skeletal reasons;
    9. Clinically significant heart disease other than coronary artery disease;
    10. Congestive heart failure stage III or IV New York heart association (NYHA);
    11. Symptomatic hypotension (<100mmHg, dizziness, orthostatic dysregulation);
    12. Uncontrolled hypertension (systolic blood pressure at rest at above 180 mmHg or diastolic blood pressure at rest above 100 mmHg);
    13. Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation;
    14. ECG abnormalities that would confound ETT interpretation;
    15. Repolarisation disturbance seen in the ECG at baseline;
    16. Hepatic disorders (alanine aminotransferase [ALT] more than 3 times normal value), renal failure (serum creatinine level above 180 µmol/l);
    17. Electrolyte disorders;
    18. Anaemia (haemoglobin below 10.0 mg/dl);
    19. Thyroid disorders (unless stable and controlled by thyroxin treatment for at least 3 months);
    20. Any treatment with unauthorised concomitant medication that could not be interrupted for the duration of the trial;
    21. Treatment with amiodarone within 3 months prior to selection;
    22. Use of bepridil < 7days before screening
    23. Use of digitalis/cardiac glycosides 6 months prior to selection;
    24. Inability or lack of consent to wash out long-acting nitrates, calcium channel blockers, trapidil, molsidomine, ranolazine, trimetazidine, nicorandil;
    25. Treatment with sildenafil (Viagra®) or other phosphodiesterase-5 inhibitors during trial participation;
    26. Severe disease likely to interfere with the trial in the investigator’s judgement;
    27. Known carrier of Hepatitis B (HBs) antigen, human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) antibodies;
    28. History of severe psychiatric or behavioural disorders likely to interfere with the trial;
    29. History of serious abnormal drug reaction;
    30. Use of investigational drug within 30 days of pre-selection, or concurrent therapy with an investigational drug(s).
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy:
    Change in Total Exercise Duration (TED) [seconds]) from baseline after 12 weeks of treatment with PETN 80 mg bid as compared to placebo bid assessed in the trough between the morning and the midday dose, (i.e. at 5 h after intake of morning dose of study medication).
    Secondary efficacy:
    - Angina attack frequency, intensity, and duration (according to patient diary);
    - Change in time to onset of anginal pain on ETT after 6 and 12 weeks of treatment;
    - Change in exercise capacity (METs) after 6 and 12 weeks of treatment
    - Concomitant use of short-acting nitrates (according to patient diary)
    - Change in time to limiting angina (TLA, seconds) during ETT after 6 and 12 weeks of treatment
    - Change in TED (seconds) during ETT after 6 weeks of treatment
    - Change in time to 1 mm ST segment depression (TST) (horizontal or down-sloping for more than 0.08 s after the J point) after 6 and 12 weeks of treatment;
    - Angina attack intensity, and duration (according to patient diary);
    - Change in Health related quality of life scores after 12 weeks of treatment;
    - Borg scale.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned39
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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 visit of last subject, estimated March 2012.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    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 2009-04-08. 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 528
    F.4.2.2In the whole clinical trial 778
    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 return to their normal standard of care after participation in the clinical trial.
    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 Decision2009-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-11
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