internal medicine research unit prospectus

Prof. Elias – Internal Medicine Research Unit
elias_m@clalit.org.il Tel: 972-4-6495590 Fax: 972-4-6526366
Internal Medicine Research Unit
We have more than 15 years of clinical trial experience and have
successfully conducted more than 33 studies, including Phase II- IV studies.
- Experience in creating source and Case Report Form (CRF) completion
and correction- electronic/ paper.
-Routine meetings with the sponsor’s monitors; we had three audits in the
past by Sanofi Aventis and Quintiles.
- The staff receives training in Human Subjects Protection, patients' safety,
Good Clinical Practices (GCP), patients' privacy and confidentiality.
Our staff are committed to patients' safety and providing excellent care.
Our Clinical Research team:
Principal Investigator: Prof. Elias Mazen
Head of internal medicine department C in Emek Medical Center, Afula,
Israel. Specialist in Internal Medicine and Hematology
 Three senior specialists in Internal Medicine, a clinical pharmacologist, a
nephrologist, and a hypertension expert.
 Two clinical trial nurses, trained in the unique processes and procedures
that are required in conducting clinical trial protocols. They are experienced
registered nurses. Both have Master’s degrees. Each protocol is assigned to
a primary nurse who coordinates the implementation of the study.
Implementation includes development of source documents and physician
orders; ensuring that all institutional approvals are completed; and ensuring
that all study personnel are trained in the study procedures.
 Clinical study coordinator, specializing in IRB submissions.
Our Facilities:
 7 Computer stations.

 Refrigerating centrifuge.
 Special room for drug storage- temperature control.
 Secure storage capabilities for study specimens which include temperature
mapped -20°C and -80°C freezers, and 2-4°C refrigerators.
 Storage room – archive.
 Staff, space, storage and equipment are all available in the unit to ensure the
correct running of the study.
 Available patient pool.
 Good relationship with other departments; emergency room, Intensive Care
Unit, Cardiac Care Unit.
 Our pharmacy complies with GCP and Good Manufacturing Practice (GMP)
requirements for drug preparation, dispensing and storage.
 Our lab complies with good laboratory practice (GLP).
Trial experience:
AF - Anti-Coagulant
Treatment, Phase III
ACS - Anti-Coagulant
Treatment, Phase II
ACS - Anti-Coagulant
Treatment, Phase III
Hyponatermia, Phase
III
AF Treatment
Phase III
RELY (2006)ACS 1(2007)ACS 2 (2009)YM087(2005)ACT V (2010)
ROCKET (2008)APPRAISE (2010)PALLAS (2011)
BOREALIS (2008)
Odyssey Outcomes
(2013)ENSURE (2015)
ENGAGE (2009)
Prevention VTE Phase
III
AF - Anti-Coagulant
Treatment, Phase IV
VTE Treatment Phase
II
VTE Treatment
Phase III
VTE Prophylaxis
Phase III
THRIVE III (1999)RELY ABLE (2007)EINSTEIN (2006)AMPLIFY (2009)MAGELLAN (2008)
LEX-203 (2004)BOTTICELLI (2006)RECOVER 2 (2009)ADOPT (2009)
EINSTEIN EXT. (2008)THRIVE II (2000)RECOVER 1(2008)
REMEDY (2008)HOKUSAI (2010)
RECORD 3 (2006)
VTE Treatment Phase
IVCASSIOPEA (2008)
AMPLIFY EXT.(2009)XALIA (2013)EINSTEIN (2007)
APEX (2012)
EINSTEIN CHOICE
(2014)

hyperlipidemia , Phase
III
Type 2 diabetes
mellitus, Phase III
Type 2 diabetes
mellitus, Phase IV
Hypertension, Phase
II
Heart Failure
Treatment , Phase
IIb
SWITCH (2011)CASCADE 8 (2011)CARMELINA (2013)REDUCE (2011)STEP WISE (2013)
Odyssey Outcomes
(2013)ITCA-650-105 (2013)
ITCA-650-107 (2013)Heart Failure
SONAR (2014)
Treatment , Phase
III
RENTIS CVO
(2015)
Prevention VTE, Phase III
THRIVE III: Oral thrombin inhibitor H 375/95 given to patients as prolonged
prophylaxis after six-month anticoagulation treatment for venous
thromboembolism, 1999-2000, AstraZeneca, Study Drug: ximelagatrn, 12
patients.
LEX-203: Efficacy & safety of Octaplex in patients under anti-coagulant
therapy & undergoing surgery or invasive procedure, 2004-2005, octapharma,
Study Drug: Octaplex, 6 patients.
EINSTEIN EXTENSION: Once daily oral direct factor Xa inhibitor Rivaroxaban
in the long-term prevention of recurrent symptomatic venous thrombo-
embolism in patients with symptomatic deep-vein thrombosis or pulmonary
embolism 2008, Bayer Health Care AG, Study drug: Rivaroxaban,16 patients.
RE-MEDY: A phase III, randomized, multicenter, double-blind, parallel-group,
active controlled study to evaluate the efficacy and safety of oral dabigatran
etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary
prevention of venous thromboembolism 2008, Boehringer Ingelheim Pharma,
Study drug: Dabigatran, 7 patients.
RECORD 3: (BAY 59-7939) Regulation of Coagulation in Orthopedic Surgery
to prevent DVT and PE 2006, Bayer, 2 patients.
AMPLIFY EXT: (CV185057) A Safety and Efficacy Trial Evaluating the Use of
Apixaban for the extende Treatment of Deep Vein Thrombosis and Pulmonary
Embolism 2009, Bristol Mayer Squibb, Study drug: Apixaban, 7 patients
APEX - Multicenter, Randomized, Active-Controlled Efficacy and Safety Study
Comparing Extended duration Betrixaban with standard of care Enoxaparin®

for the prevention of Venous Thromboembolism in acute medically ill patients,
10 patients
EINSTEIN CHOICE – Reduced-dosed Rivaroxaban and standard-dosed
Rivaroxaban versus ASA in the long term prevention of recurrent symptomatic
Venous Thromboembolism in patients with symptomatic deep vein thrombosis
and/or Pulmonary Embolism, 8 patients – on going
Atrial Fibrillation Treatment, Phase III
ACT V: A Phase 3b, Double-Blind, Placebo Controlled, Parallel Group Study
to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in
Patients with Recent Onset Symptomatic Atrial Fibrillation 2010, Astellas
Pharma Global Development, Study Drug: Vernakalant Hydrochloride, 3
patients
PALLAS: Randomized, Double-Blind, Placebo controlled, Parallel group trial
for assessing the clinical benefit of Dronedarone 400mg BID on top of
standard therapy in patients with permanent atrial fibrillation and additional risk
factors 2011, Population Health Research Institute & Sanofi Aventis, Study
Drug: Dronedrone, 3 patients
ENSURE AF - A Prospective, Randomized, Open-label, Blinded Endpoint
Evaluation (PROBE) Parallel group study comparing Edoxaban(DU-176b) with
Enoxaparin/Warfarin followed by Warfarin alone in subjects undergoing
planned electrical cardioversion of Non-Valvular Atrial Fibrillation, 2 patients
Atrial Fibrillation – Anti-Coagulation Treatment, Phase III
RELY: Randomized Evaluation of Long term anticoagulant therapy
(RE-LY) comparing the efficacy & safety of two blinded doses of dabigatran
etexilate with open label warfarin for the prevention of stroke and systemic
embolism in patients with non-valvular atrial fibrillation: prospective,
multi-center, parallel-group, non-inferiority trial ,2006-2007, Boehringer
Ingelheim Pharma, Study drug: Dabigatran, 40 patients.
ROCKET: A Prospective, Randomized, Double-Blind, Double Dummy,
Parallel-Group, Multicenter, Study Comparing the Efficacy and Safety of
Once-Daily Oral Rivaroxaban (BAY 59-7939) with Adjusted-Dose Oral
Warfarin for the Prevention of Stroke and Non-Central Nervous System
Systemic Embolism in Subjects with Non-Valvular Atrial Fibrillation 2008,
Bayer Health Care AG, Study drug: Rivaroxaban,14 patients.
BOREALIS: A multicenter, randomized, double-blind, study comparing the
efficacy and safety of once-weekly subcutaneous biotinylated idraparinux
(SSR126517E) with oral warfarin in the prevention of stroke and systemic

thromboembolic events in patients with AF 2008, Sanofi Aventis Recherche,
Study drug: Idraparinux, 15 patients.
ENGAGE: A Phase III, Randomized, Double-Blind, Double-Dummy, Parallel
Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety
of DU-176b Versus Warfarin In Subjects with Atrial Fibrillation – Effective
Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation 2009,
Daiichi Sankyo, Study drug: Edoxaban, 29 patients.
Atrial Fibrillation – Anti-Coagulation Treatment, Phase IV
RELY-ABLE: Long term, Multi-center, extension of Dabigatran treatment
inpatients with Atrial Fibrillation who completed the RE-LY trial and a cluster
randomized trial to assess the effect of a knowledge translation intervention on
patients outcome 2007, Boehringer Ingelheim Pharma, Study drug:
Dabigatran, 12 patients.
VTE Treatment, Phase II
EINSTEIN: Factor Xa inhibitor in patients with acute symptomatic deep vein
thrombosis, 2006,bayer Study Drug: rivaroxaban ,7 patients.
BOTTICELLI: (CV 185-017) A phase II randomized, parallel arm study of oral
direct factor Xa-inhibitor Apixaban & low molecular weight heparin or
Fondaparinux with a vitamin K Antagonist in subject with Acute symptomatic
deep vein thrombosis, 2006, Bristol-Myers Squibb, Study Drug: Apixaban ,
13 patients.
THRIVE II: A double-blind international study, efficacy and safety of the oral
thrombin inhibitor H 376/95 Vs standard therapy (enoxaparin & warfarin) for
acute, symptomatic deep vein thrombosis with or without pulmonary embolism.
2000-2002, AstraZeneca, Study Drug: H 376/9 , 11 patients.
VTE Treatment, Phase III
RE-COVER I: A phase III, randomized, double blind, parallel-group study of
the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to
warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous
thromboembolism, following initial treatment (5-10 days) with a parenteral
anticoqgulant approved for this indication 2008, Boehringer Ingelheim Pharma,
Study Drug: Dabigatran, 2 patients.
EINSTEIN: Oral direct factor Xa inhibitor rivaroxban in patients with acute
symptomatic deep-vein thrombosis or pulmonary embolism 2008, Bayer
Health Care AG, Study Drug: Rivaroxaban, 60 patients.

CASSIOPEA: An international, multi-center, randomized, double-blind, double-
dummy, parallel group, study of 3-month or 6-month treatment with
SSR126517E (3.0 mg S.C. once weekly) versus oral INR-adjusted warfarin in
the treatment of patient with symptomatic pulmonary embolism, with or without
symptomatic deep venous thrombosis 2008, Sanofi Aventis, Study Drug:
Idraparinux, 8 patients.
AMPLIFY: (CV185056) A Safety and Efficacy Trial Evaluating the Use of
Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and
Pulmonary Embolism 2009, Bristol-Mayer Squibb, Study Drug: Apixaban, 16
patients
RE-COVER II: A phase III, randomized, double blind, parallel-group study of
the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to
warfarin (INR 2.0-3.0) for 6 month treatment of acute symptomatic venous
thromboembolism, following initial treatment for at least 5 days with a
parenteral anticoqgulant approved for this indication 2009, Boehringer
Ingelheim Pharma, Study Drug: Dabigatran, 12 patients.
HOKUSAI: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel-
Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and
Safety of Heparin/Edoxaban Versus Heparin/Warfarin in Subjects with
Symptomatic Deep-Vein Thrombosis and/or Pulmonary Embolism 2010,
Daiichi Sankyo, Study Drug: Edoxaban, 38 patients.
VTE Treatment, Phase IV
XALIA – Xarleto for Long-term and Initial Anticoagulation in Venous
Thromboembolism (VTE), 26 patients
Acute Coronary Syndrome – Anti-Coagulation Treatment, Phase II
ATLAS ACS TIMI: A Randomized, Double-Blind, Placebo controlled,
Multicenter, Dose-Escalation and dose-confirmation study to evaluate the
Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with
Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes
2007, Janssen-Cilag International, Study drug: Rivaroxaban,16 patients.
Acute Coronary Syndrome – Anti-Coagulation Treatment, Phase III
ATLAS ACS 2 TIMI 51: The second trial of Anti-Xa Therapy to Lower
cardiovascular events in Addition to standard therapy in Subjects with Acute
Coronary Syndrome 2009 ,Janssen-Cilag International, Study drug:
Rivaroxaban,51 patients.

APPRAISE 2: A Phase 3, Randomized, Double-Blind, Evaluation of the Safety
and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome
2010, Bristol-Mayer Squibb, Study Drug: Apixaban, 6 patients.
ODYSSEY OUTCOMES - A Randomized, Double-Blind, Placebo-Controlled,
Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the
Occurrence of Cardiovascular Events in Patients Who Have Recently
Experienced an Acute Coronary Syndrome, 9 patient
VTE Prophylaxis, Phase III
MAGELLAN: Multi-center, randomized, parallel group efficacy superiority
study in hospitalized medically ill patients comparing Rivaroxaban with
Enoxaparin 2008,
Bayer Health Care AG, Study Drug: Rivaroxaban, 39 patients.
ADOPT: A Phase 3 Randomized, Double-Blind, Parallel-Group, Multi-Center
Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous
Thrombo-embolism in Acutely Ill Medical Subjects During and Following
Hospitalization 2009, Bristol-Mayer Squibb, Study Drug: Apixaban, 26 patients.
Hyponatermia, Phase III
YM087: Multi-center phase 3b study of IV YM087 to assess safety in patients
with euvolemic or hypervolemic hyponatremia, 2005, Astellas Pharma Inc,
Study Drug: YM087 ,14 patients.
Hyperlipidemia, Phase III
SWITCH: A Randomized, Double-Blind, Active-Controlled, Multicenter Study
of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk
Who are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of
the Efficacy and Safety of Switching to Coadministration Ezetimibe and
Atorvastatin Versus Doubling the dose of Atorvastatin or Switching to
Rosuvastatin 2011, Merck & Co. Inc., Study Drug: Atorvastatin, 5 patients
Type 2 Diabetes Mellitus, Phase III
ITCA - ITCA 650-CLP-105: A Phase 3, Randomized, Active Comparator,
Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and
Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in
Patients with Type 2 Diabetes, 2 patients
ITCA - ITCA 650-CLP-107: A Randomized, Multicenter Study to Evaluate
Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of
Care for Type 2 Diabetes, 8 patients

CASCADE-8 - A Phase III, multicentre, international, randomized, parallel
group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg
administered orally once daily) compared to usual care in type 2 diabetes
mellitus patients with increased cardiovascular risk, 2011-2013, 25 patients
SONAR - A Randomized, Multicountry, Multicenter, Double Blind, Parallel,
Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in
Subjects with Type 2 Diabetes and Nephropathy, 2 patients – On going
TRUE AHF - Phase III, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin)
Intravenous Infusion in Patients Suffering from Acute Decompensated Heart
Failure
MK-8835 - Randomized, Double-blind, Placebo-controlled, Parallel group
study to assess Cardiovascular Outcomes following treatment with Ertugliflozin
(MK-8835/PF-04971729) in subjects with Type 2 Diabetes Mellitus and
established Vascular Disease, 19 patients
Type 2 Diabetes Mellitus, Phase IV
CARMELINA – A multi center, International, Randomized, Parallel group,
Double-blind, Placebo controlled Cardiovascular safety & Renal microvascular
outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes
mellitus at high vascular risk, 29 patients – On going
Hypertension, Phase II
REDUCE 1 - A multi-center, double-blind, randomized, placebo- and active-
controlled, parallel-group, proof-of-concept study to evaluate the efficacy,
safety, and tolerability of 10 mg of ACT-280778 in patients with mild to
moderate essential hypertension, 2011-2012, 2 patients
Heart Failure Treatment, Phase IIb
STEP WISE – A phase 2b Randomized, Double-blind, Multi-center study
comparing Cross-Linked Polyelectrolyte (CLP) with Placebo in Heart Failure
subjects, 1 patient

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