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EudraCT CAESAR

EudraCT CAESAR . CAESAR: C linic a l e fficacy s tudy of Pent a long ® on Pulmonary Hypertension in Heart Failu r e. EudraCT CAESAR . Actavis : Sponsor of the study N.N. – Project management

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EudraCT CAESAR

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  1. EudraCT CAESAR CAESAR: Clinical efficacy study of Pentalong® on Pulmonary Hypertension in Heart Failure

  2. EudraCT CAESAR Actavis: Sponsor ofthestudy N.N. – Project management – Site management & monitoring – Clinical datamanagement (E-CRF set up IVRS) – Medical monitoring and safety reporting Next Pharma: – Study drug (re-)supply

  3. EudraCT CAESAR QUALITY ASSURANCE: - Central Haemodynanicreading by cardiologist Prof. Dr. med. Veselin Mitrovic, Bad Nauheim - Data SafetyMonitoring Board Scientific advisory board Prof. Dr. med. C. Bode, Freiburg Prof. Dr. med. Böhm, Homburg Prof. Dr. med. E. Erdmann, Köln (principal Investigator) Prof. Dr. med. T. Meinertz, Hamburg Prof. Dr. med. A. Mügge, Bochum Prof. Dr. med. G. Nickenig, Bonn Prof. Dr. med. R. Strasser, Dresden

  4. EudraCT CAESAR Study Purpose - On the background of the Erdmann/Schneider Case reports trial medical treatment with PETN in Patients suffering from PH has received more attention. - Data from pre-clinical studies have revealed beneficial effects of PETN on the endothelium due to anti-oxidative properties. - Furthermore the phenomenon of nitrate tolerance is not observed with long-termPETN treatment

  5. EudraCT CAESAR Study Objectives Primary objective : The primary objective of this trial is to show superiority of PETN over Placebo of a 12 week oral Pentalong®therapy in addition to standard long-term HF medication on PVR in patients suffering from HF Secondaryobjectives: A secondary objective is to evaluate the safety and tolerability of Pentalong® therapy on exercise capacity (6MWD); echocardiographic variables (PAPsyst, LVEF, FS, TAPSE); right heart catheter variables (PCWP, PAPs, PAPd, PAPm, RAP, RVSP, RVEDP); quality of life (QOL-Questionaire MLHFQ); biomarkers (NTproBNP, optional: CT-proET-1, MR-proADM, Troponin-I)

  6. EudraCT CAESAR Study Design phase II, randomised, double-blind, placebo-controlled, multicentre trial(approximately 15 centresin University Hospitals in Germany) 120 patients will be screened to obtain 100 randomisedpatients 80 evaluablepatients(40 patients per group) Subjects (>18- <80 years) suffering from heart failure NYHA II-IV and secondary pulmonary hypertension - Randomization in a 1:1 ratio to one of two treatment arms to receive either PETN 80 mg bid or placebo

  7. EudraCT CAESAR

  8. EudraCT CAESAR Study Design V- 1 Day: History, PhysicalExamination, Patient Information V- 2 Day: Run-in screening WrittenInformedConsent, Test Medication V - 3 Day PhysicalExamination, Blood Sampling, BaselineAssessment, Randomization V - 4 Day History, PhysicalExamination, Blood Sampling, End of Study Assessment, studyclose out -

  9. EudraCT CAESAR Study Treatment TID p.o Study medikation for 12 weeks in on top of stable treatment regimen for HF according to ESC guidelines since at least 3 months. Group I: Pentaerythrityltetranitrate(PETN) 80 mg p.o. tid Group II: Placebo p.o. tid

  10. EudraCT CAESAR Study Treatment run-in screening phase one oral Pentalong® tablet three times daily double-blind treatment phase one oral placebo tablet or one oral tablet of PETN 80 mg three times daily On visit days (Visit 3 and 4): – The midday tablet has to be taken at the study site after the assessment was performed – The morningtablet 4-6 hrspriorAssessment – Time of tablet intake in morning and afternoon to be completed in CRF

  11. EudraCT CAESAR Selection Criteria Women or men > 18 and < 80 years of age documented HF (NYHA II-IV) secondary PH (PAPm >30mmHg, PCWP >15mmHg, LVEF < 45%) stable treatment regimen for HF according to ESC guidelines since at least 3 months

  12. EudraCT CAESAR Exclusion Criteria visible clinical signs of acutely decompensated HF hypotension (RR<100mmHg), HF NYHA I, myocarditis, acute coronary syndrome, severe primary valvular diseases, atrial fibrillation, contraindications or hyperrespositivity to nitrovasodilators, implantation of CRT < 12 months heart transplantation on “high urgency” status

  13. EudraCT CAESAR Exclusion Criteria Following medications: Nitrates, NO-Donors, hydralazin, PDE-5 inhibitors unstable treatment regimen for HF according to ESC guidelines since at least three months noncardiac limitation to exercise pregnant or breast feeding women

  14. EudraCT CAESAR Discontinuation of Study Drug Reasons for Patients withdrawn - own request (withdrawal of consent) - investigator’s opinion, for reasons of safety or ethics, continuation in the study would be detrimental to the patient’s well-being - majorprotocolviolations - at the specific request of the sponsor - breakingofrandomisationcode Withdrawals will not be replaced

  15. EudraCT CLEOPATRA 2008-007093-37 SelectionCriteria (day -14; day -7) Initial examination (inclusionvisit): - Voluntarily given informed consent - consent to data recording and verification procedures - Male or female patients or outpatients aged at least 18 years History of chronic, stable, effort-induced AP for at least 3 months prior to inclusion (effort angina defined as typical or untypical angina pain associated with physical activity, lasting several minutes and disappearing with cessation of physical activity and/or administration of short-actingnitrates) - Analysable ST Segment on 12-lead ECG: morphology of ST segment within normal limits, and no electrocardiographic state that precludes ST segment interpretation at rest or during exercise, and – sinusrhythm - In the investigator's opinion, the patient's state of health must allow the patient to take part in the trial -

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