CENTER FOR CLINICAL TRIALS St. Luke s Medical Center. Ongoing Clinical Trials DEPARTMENT OF MEDICINE (24)

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1 CENTER FOR CLINICAL TRIALS St. Luke s Medical Center Ongoing Clinical Trials DEPARTMENT OF MEDICINE (24) Arthritis TITLE : A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen [PRECISION: Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs. Ibuprofen Or Naproxen] PROTOCOL NUMBER : A PRINCIPAL INVESTIGATOR : Juan Javier T. Lichauco, MD CONTACT NUMBER : For more details, click this link TITLE : A Phase IIB, 12 Week Radomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Evaluate Efficacy, Safety And Tolerability Of 2, 4 And 6 Mg Of Revamilast In Patients With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate PROTOCOL NUMBER : GRC PRINCIPAL INVESTIGATOR : Juan Javier T. Lichauco, MD CONTACT NUMBER : For more details, click this link TITLE : A Randomized, Double-Blind, Parallel-Group, Phase 1 Study To Evaluate The Initial Pharmacokinetics, Efficacy, And Safety Of CT-P13 Compared With Remicade When Co-Administered With Methotrexate In Patients With Active Rheumatoid Arthritis PROTOCOL NUMBER : CT-P PRINCIPAL INVESTIGATOR : Dr. Sandra V. Navarra, MD; Celltrion, Inc. CONTACT NUMBER :

2 TITLE : A Randomized, Double-Blind, Parallel-Group, Phase 3 Study To Demonstrate Equivalence In Efficacy And Safety Of CT-P13 Compared With Remicade When Co-Administered With Methotrexate In Patients With Active Rheumatoid Arthritis PROTOCOL NUMBER : CT-P PRINCIPAL INVESTIGATOR : Sandra V. Navarra, MD CONTACT NUMBERS : TITLE : A Randomized, Double-Blind, Parallel Group Study Of The Safety And Effect On Clinical Outcome Of Tocilizumab SC Versus Tocilizumab IV, In Combination With Traditional Disease Modifying Anti-Rheumatic Drugs (Dmards), In Patients With Moderate To Severe Active Rheumatoid Arthritis PROTOCOL NUMBER : WA22762 PRINCIPAL INVESTIGATOR : Juan J. Lichauco, MD CONTACT NUMBERS : For more details, click this link TITLE : A Two-Part, Phase 1 Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study To Assess The Pharmacokinetics, Safety, And Tolerability Of MK-8808 And To Compare The Pharmacokinetics Of MK-8808 With Rituximab (Mabthera ) In Patients With Rheumatoid Arthritis (RA) PROTOCOL NUMBER : MK PRINCIPAL INVESTIGATOR : Paul V. Santos-Estrella, MD CONTACT NUMBERS : For more details, click this link TITLE : A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of Secukinumab To Demonstrate The Efficacy At 24 Weeks And To Assess The Long Term Safety, Tolerability And Efficacy Up To 2 Years In Patients With Active Psoriatic Arthritis/ CAIN457F2306 (Phase III) PROTOCOL NUMBER : CAIN457F2306

3 PRINCIPAL INVESTIGATOR : Juan Javier T. Lichauco, MD STUDY COORDINATOR : Irene Guña CONTACT NUMBERS : For more details, click this link TITLE : A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial Of Golimumab, a Fully Human Anti-TNF? Monoclonal Antibody, Administered Subcutaneously, In Methotrexate-Naive, Subjects With Active Rheumatoid Arthritis (C054TO5) PROTOCOL NUMBER : C054TO5 PRINCIPAL INVESTIGATOR : Juan Javier T. Lichauco, MD CONTACT NUMBERS : For more details, click this link TNF+golimumab&rank=8 Diabetes TITLE : A Multicenter, International, Randomized, 2x2 Factorial Design Study To Evaluate The Effects Of Lantus (Insulin Glargine) Vs Standard Care, And Of Omega-3 Fatty Acids Vs Placebo In Reducing Cardiovascular Mortality In High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT), Or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Insulin Glargine Intervention PROTOCOL NUMBER : HOE PRINCIPAL INVESTIGATOR : Ricardo E. Fernando, MD STUDY COORDINATOR : Paz Figueroa CONTACT NUMBER : For more details, click this link TITLE : A Randomized, Double-Blind, Placebo- And Active-Controlled, Parallel- Group, Multicenter Study To Determine The Efficacy And Safety Of Albiglutide When Used In Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, And Metformin Plus Placebo In Subjects With Type 2 Diabetes Mellitus

4 PROTOCOL NUMBER : GLP PRINCIPAL INVESTIGATOR : Gabriel V. Jasul, MD STUDY COORDINATOR : Cristobal Pesa CONTACT NUMBERS : For more details, click this link TITLE : A Randomized, Double-Blind, Placebo- And Active-Controlled, Parallel-Group, Multicenter Study To Determine The Efficacy And Safety Of Albiglutide Administered In Combination With Metformin And Glimepiride Compared With Metformin Plus Glimepiride And Placebo And With Metformin Plus Glimepiride And Pioglitazone In Subjects With Type 2 Diabetes Mellitus PROTOCOL NUMBER : GLP PRINCIPAL INVESTIGATOR : Gabriel V. Jasul, MD STUDY COORDINATOR : Cristobal Pesa CONTACT NUMBERS : For more details, click this link TITLE : A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin In Addition To Standard Of Care In Subjects With Type 2 Diabetes And Acute Coronary Syndrome (Phase 3b); PROTOCOL NUMBER : (SYR-322_402) PRINCIPAL INVESTIGATOR : Gabriel V. Jasul Jr, MD STUDY COORDINATOR : Cristobal Pesa CONTACT NUMBERS : For more details, click this link TITLE : Asian Treat To Target Lantus Study: A Randomized, Multicentre, Multinational, Open-Label, Parallel-Group, 24-Week Phase IV Study Evaluating The Effectiveness And Safety Of Physician Versus Patient-Led Initiation And Titration Of Insulin Glargine In Type 2 Diabetes Mellitus (ATLAS Study) PROTOCOL NUMBER : LANTU_R_04889 PRINCIPAL INVESTIGATOR : Roberto C. Mirasol, MD STUDY COORDINATOR : Luna Reyes

5 CONTACT NUMBERS : For more details, click this link TITLE : A Phase III Randomised, Double-Blind, Active-Controlled Parallel Group Efficacy And Safety Study Of BI Compared To Glimepiride Administered Orally During 104 Weeks In Patients With Type 2 Diabetes Mellitus And Insufficient Glycaemic Control Despite Metformin Treatment PROTOCOL NUMBER : BI PRINCIPAL INVESTIGATOR : Ricardo E. Fernando, MD STUDY COORDINATOR : Alice Vega CONTACT NUMBERS : For more details, click this link TITLE : A Multicenter, Randomized, Double-Blind, Active-Controlled Study To Evaluate The Durability Of The Efficacy And Safety Of Alogliptin Compared To Glipizide When Used In Combination With Metformin In Subjects With Type 2 Diabetes PROTOCOL NUMBER : SYR-322_305 PRINCIPAL INVESTIGATOR : Elizabeth Ann Fernando-Catindig, MD STUDY COORDINATOR : Levita C. Vitug CONTACT NUMBERS : For more details, click this link TITLE : A Multinational, Multicenter, Post-Authorization, Prospective Observational Cohort Study To Assess The Profile Of Vidagliptin And The Fixed-Dose Combination Of Vildagliptin/Metformin Relative To Comparator Oral Anti-Diabetic Drugs In Patients With Type2 Diabetes In a Real-World Setting PROTOCOL NUMBER : CLAF237A2403 PRINCIPAL INVESTIGATOR : Gabriel V. Jasul Jr., MD STUDY COORDINATOR : Cristobal C. Pesa CONTACT NUMBERS : For more details, click this link TITLE : An Observational, Multinational, Multi-Center Prospective Cohort Study To Assess Effectiveness, Safety And Tolerability Of Treatment With Vildagliptin Or Single Pill Combination Of Vildagliptin/Metformin

6 In Type 2 Diabetes Mellitus In Real-World Setting/ GUARD Study PROTOCOL NUMBER : CLAF237A-MAX-PH-01 PRINCIPAL INVESTIGATOR : Reynaldo F. Rosales, MD STUDY COORDINATOR : Madonna Lozano CONTACT NUMBERS : TITLE : A Multicentre, International, Randomised, Parallel Group, Double Blind Study To Evaluate Cardiovascular Safety Of Linagliptin Versus Glimepiride In Patients With Type 2 Diabetes Mellitus At High Cardiovascular Risk PROTOCOL NUMBER : BI / CAROLINA TRIAL PRINCIPAL INVESTIGATOR : Gabriel V. Jasul, Jr., MD STUDY COORDINATOR : Cristobal Pesa CONTACT NUMBERS : For more details, click this link Others TITLE : A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Subcutaneous LY In Patients With Systemic Lupus Erythematosus (SLE) PROTOCOL NUMBER : H9B-MC-BCDS PRINCIPAL INVESTIGATOR : Sandra V. Navarra, MD; Eli Lilly And Company CONTACT NUMBERS : For more details, click this link TITLE : Evaluation Of Chronic Kidney Disease Practice Pattern Through The Global Renal Information Database (GRID) Project PROTOCOL NUMBER : GRID-CKD Project PRINCIPAL INVESTIGATOR : Benjamin A. Balmores, MD

7 CONTACT NUMBER : TITLE : A Post-Marketing Surveillance Study On The Effectiveness, Safety And Tolerability Of Telbivudine (Sebivoâ ) 600 Mg Once Daily In The Treatment Of Chronic Hepatitis B Among Filipino Patients PROTOCOL NUMBER : CLDT600APH01 PRINCIPAL INVESTIGATOR : Randy Mercado, MD CONTACT NUMBER : loc.329 TITLE : Renvela Post Marketing Surveillance Study In The Philippines Under The Modified Release Program PROTOCOL NUMBER : Renvela PRINCIPAL INVESTIGATOR : Benjamin A. Balmores, MD CONTACT NUMBER : TITLE : A Descriptive Study Of The Efficacy And Safety Of ONGLYZA (Saxagliptin) Under Conditions Of Actual Use In The Philippines PROTOCOL NUMBER : D1680L0007 PRINCIPAL INVESTIGATOR : Michael L. Villa, MD CONTACT NUMBER : For more details, click this link TITLE : A Comparison Of Tuberculin Skin Test And Interferon-Gamma Release Assay Test Response In Individuals With Strong Risk Factors For The Development Of Tuberculosis Due To Immune Compromise With The Same Response In Healthy Household Members Without Immune Compromise

8 PROTOCOL NUMBER : PRINCIPAL INVESTIGATOR : Paul V. Santos Estrella, MD CONTACT NUMBER :