LIST OF STUDIES WITH RESPECTIVE FUNDING AGENCY JANUARY 2006 – JANUARY 2014 Principal S. No Department Title Funding Agency Investigator A randomized, double-blind, placebo-controlled, parallel group study to determine whether, in patients with type 2 diabetes at AACT – Academic 1 Dr. Nihal Thomas Endocrinology high risk for cardiovascular and renal events, aliskiren, on top of Alliance for Clinical conventional treatment, reduces cardiovascular and renal Trials morbidity and mortality. This prospective, open label, multi –center, observational, single- 2 Dr. Sunil Chandy Cardiology arm registry is designed to XIENCE VEECSS continued safety and Abbott Vascular effectiveness during commercial use in real world settings. Prospective, randomized, placebo-controlled, double-blind, Dr. Debashish Clinical Immunology multicenter, parallel group study to assess the efficacy, safety and 3 Actelion Danda & Rheumatology tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. Targeted Second- Generation Resequencing for the Molecular 4 Dr. Nihal Thomas Endocrinology Genetic Diagnosis of Maturity Onset Diabetes of the Young Actelion (MODY). A randomized, active therapy controlled phase 2 study to assess Advaxis Inc, North 5 Dr. Subhashini John Radiation Therapy the safety and efficacy of ADXS11-001 with or without Cisplatin Brunswick as 2nd line therapy for the treatment of recurrent cervix cancer. A multicentre, open label, parallel group, randomized, phase IIB Adventrux Dr. Raju Titus clinical trial to evaluate the safety and efficacy of CofactorTM and 6 Medical Oncology Pharmaceuticals, Chacko 5-FU versus Leucovorin and 5-FU in subjects with Metastatic USA colorectal carcinoma. FORTIS-M: A phase 3, randomized, double-blind, placebo- controlled study of oral talactoferrin in addition to best 7 Dr. Subhashini John Radiotherapy Agennix Inc. supportive care in patients with non-small cell lung cancer who have failed two or more prior treatment regimens. AIDS International The BV study: Relationship of Lactobacillus and its phages in training and 8 Dr. Shalini Anandan Clinical Microbiology bacterial vaginosis among women in India. research programme An evaluation of the safety and efficacy of Moxifloxacin AF Dr. Andrew 9 Ophthalmology Opthalmic solution 0.5% for the treatment of Bacterial Alcon Research Ltd. Braganza conjunctivitis in India. A 6 day, Phase 3, Multicenter, Randomized, Double-Masked, Parallel Study to compare the safety and efficacy of Gatifloxacin 10 Dr. Sanita Korah Ophthalmology Allergan 0.5% ophthalmic solution BID with that of vehicle in the treatment of acute bacterial conjunctivitis. Allergan. A Multicentric, double blind, randomized, placebo controlled, paralled group, study to explore the dose dependent response to 11 Dr. Ninan K Chacko Urology three dose levels of Botox (Botulinum Toxin Type A) purified Allergan neurotoxin complex followed by an open label extension phase in patients with urinary incontinence due to neurogenic detrusor overactivity. A multicentric, double blind, randomized, placebo controlled, paralled group, study to explore the dose dependent response to 12 Dr. Ninan K Chacko Urology three dose levels of Botox purified neurotoxin complex followed Allergan by an open label extension phase in patients with urinary incontinence due to neurogenic detrusor overactivity. A randomized, double blind, multicenter, study of Denosumab compared with Zolerdronic Acid (Zometa) in the treatment of 13 Dr. Subhashini John Radiotherapy II Amgen Inc bone metastases in men with hormone refractory prostate cancer. A randomized, double blind, multicenter, study of Denosumab 14 Dr. Subhashini John Radiotherapy II compared with Zolerdronic Acid (Zometa) in the treatment of Amgen Inc bone metastases in subjects with advanced breast cancer. A randomized, double-blind, multicenter study of Denosumab Dr. Raju Titus compared with zoledronic acid (Zometa) in the treatment of bone 15 Medical Oncology Amgen Inc, USA Chacko metastases in subjects with Advanced Cancer (excluding breast and prostate cancer) or multiple myeloma. A phase 2, multicenter, open label, randomized trial of AMG 706 Dr. Raju Titus or Bevacizumab in combination with Paclitaxel and Carboplatin 16 Medical Oncology Amgen Inc. Chacko for advanced non-squamous non-small cell lung cancer. Protocol No. 20060136. 17 Dr. Thomas V Paul Endocrinology A Multicenter, International, randomized, Double-blind, Placebo- Amgen, Inc controlled, Parallel-group study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women with Osteoporosis. Aquaya Institute, Qualitative investigation of community & professional groups in CA, USA and 18 Dr. Vinohar Balraj Community Health India and their interest in water testing. University of Bristol Assessment of an anti-TFPI aptamer: ARC19499 in correcting the Archemix Corp, 19 Dr. Alok Srivastava Haematology abnormal hemostasis of blood from patients with hemophilia and Cambridge, MA, evaluation of its concentration-effect relationship. USA An open-label study investigating long-term safety and tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Archimedes 20 Dr. Reena George Palliative Care Unit treatment of Breakthrough Cancer Pain (BTCP) in patients taking Development Ltd. regular opioid therapy. Improving health worker and Emergency medical technician and 21 Dr. Anand Zachariah Medicine Emergency response centre physician knowledge, skills and Asia Pacific practice in first aid and transport in acute poisoning Asian Network for A multicenter, multinational serosurvey study for Pertussis 22 Dr. V. Balaji Clinical Microbiology Study of Resistant among children 10-18 years old in Asia Pathogens 23 Dr. Debashish Clinical Immunology ACR/EULAR diagnostic and classification criteria for vasculitis Association of Danda & Rheumatology Medical Toxicology An open label, multi-centre, prospective study to demonstrate Astellas Pharma 24 Dr. V. Tamilarasi Nephrology safety and efficacy of once daily Advagraf in patients undergoing India Pvt. Ltd kidney or liver transplantation in India. A double blind, placebo controlled, parallel group, multicentre, randomized, Get Ethics phase 11 survival study comparing ZD AstraZeneca Dr. Raju Titus 1839 (IRESSATM ) (250 mg tablet) plus Committee best 25 Medical Oncology Pharma Private Chacko supportive care in patients with advanced NSCLC who have Limited, Bangalore received one or two prior chemotherapy regimens and who are refractory or intolerant to their most recent regimen. A Multicentre, Randomised, Double-blind, placebo-controlled, AstraZeneca 26 Dr. Dilip Mathai Medicine Unit I study on the use of Prophylactic Meropenem in patients with Pharma Private Severe Acute Necrotizing Pancreatitis. Limited, Bangalore A phase II randomized, double blind, placebo controlled, multicentre comparative study of ZD1839 250 mg or 500 mg AstraZeneca (IressaTM) given either continuously or concomitantly with 27 Dr. Subhashini John Radiotherapy - II Pharma Private Cisplatin plus Radiotherapy for the treatment of patients with Limited, Bangalore previously untreated unresected late stage III/IV non-metastatic Head and Neck squamous cell carcinoma. A Phase II, Randomised, Double-blind, Placebo-controlled, Multi- centre Study to Assess the Efficacy and Safety of AZD8931 In AstraZeneca 28 Dr. Subhashini John Radiotherapy Combination with Anastrozole, Compared to Anastrozole alone, Pharma Private in Post-menopausal Women With Hormone Receptor-positive, Limited, Bangalore Endocrine Therapy-naive, Locally-advanced or Metastatic Breast Cancer (MINT) A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous AstraZeneca 29 Dr. DJ Christopher Pulmonary Medicine Ceftaroline Fosamil Versus Intravenous Ceftriaxone in the Pharma Private Treatment of Adult Hospitalised Patients With Community- Limited, Bangalore Acquired Bacterial Pneumonia in Asia. A phase III, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 10 mg ZD4054 in combination AstraZeneca Dr. Raju Titus 30 Medical Oncology with docetaxel in comparison with doccetaxel in comparison Pharma Private Chacko with docetaxel in patients with metastatic hormone-resistant Limited, Bangalore prostate cancer. A phase III, randomized, double-blinded, multi-center study to assess the efficacy of Docetaxel (TAXOTERETM) in combination AstraZeneca Dr. Raju Titus with ZD6474 (ZACTIMATM) versus Docetaxel (TAXOTERETM) in 31 Medical Oncology Pharma Private Chacko combination with placebo in patients with locally advanced or Limited, Bangalore metastatic (Stage IIIB-IV) non-small cell lung cancer (NSCLC) after failure of 1st Line anti-cancer therapy. D4200C0032. A Phase III, Randomized, Double-blinded, Parallel Group, Multi- centre, study to assess the Efficacy and Safety of ZD6474 AstraZeneca Dr. Raju Titus (ZACTIMATM) in combination with pemetrexed (Alimta®) 32 Medical Oncology Pharma Private Chacko versus Pemetrexed alone in patients with locally advanced or Limited, Bangalore metastatic (stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) after failure of 1st line anti-cancer. 33 Dr. Subhashini John Radiotherapy - II A randomized, double blind, parallel – Group, multicentre, phase AstraZeneca III study comparing the efficacy and tolerability of Fulvestrant Pharma Private (FASLODEXTM) 500mg with Fulvestrant (FASLODEXTM) 250mg Limited, Bangalore in Postmenopausal in Estrogen Receptor Positive advanced breast cancer