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1

A 26 week extension to a 26-week treatment,  multi-center, randomized, double-blind, placebo controlled, adaptive, seamless, parallel group study to assess the safety, tolerability and efficacy of two doses of indacaterol  (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease – Dr.C.Nagaraj, Prof. & HOD of Pulmonary Medicine, BMCRI.

2

A 26-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of two doses of indacaterol (selected from 75, 150, 300 & 600 ug o.d.) as active controls – Dr.Veeranna Gowda, Prof. of Medicine, BMCRI.

4

Multinational, Multicenter, Randomized, Double  Blind Study comparing the Efficacy and Safety of AVE5026 with enoxaparin for the prevention of Venous Thromboembolism in Patient Undergoing Major Abdominal Surgery- Dr.M.K.Ramesh, Prof. of Surgery, BMCRI.

5

“A Phase 3 Randomized, Placebo-and Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of two Doses of Lurasidone HCI in Acutely Psychotic Patients with Schizophrenia” - Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

6

“A Double blind, Randomized, Placebo-controlled, Questiapine-referenced, Muliticentre Study of the Long-term Bifeprunox Efficacy, Safety and Tolerability in Patients with Chronic Stable Schizophrenia” - Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

7

Randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, dose-finding study of Lu AA24530 in Major Depressive Disorder. - Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

8

Data Acquisition on TBDr.Shashidara Buggi, Medical Superintendent & Prof. & HOD of C.T.Surgery, BMCRI

9

Pan Asia Epidemiologic surveillance Network to assess the burden of invasive pneumococcal diseaseDr.Premalatha, Prof. of  Paediatrics, BMCRI.

10

A Phase I/II study to evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis. Dr. Leelavathi, Asst. Prof. of Dermatology

11

A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 2 – 8 mg in the Treatment of Major Depressive Disorder with Subjects who are Partial Responders or Non-Responders to Citalopram Therapy –  Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

12

A double-blind, randomized, placebo-controlled, multicentre study to assess the efficacy and safety of Euphorbia Prostrata dry extract tablets in Patients of 1 and 2 internal Haemorrhoids. (No. PANBIO/CR0042006/CT) – Dr.T.Duruganna, Prof. of Surgery, BMCRI.

13

A multicentric, single blind, parallel, randomized phase-III study to evaluate the immunogenicity and safety  of BE’s reconstituted pentavalent vaccine (Haemophilus influenzae type B tetanus conjugate vaccine reconstituted with DTwP-rHepatitis-B vaccine) administered to 6-8 week old healthy Indian infants at 6-10-14 weeks in comparison with GSK’s Hiberix TM reconstituted with Tritanrix TM – HB vaccine- A non-inferiority study. – Dr.Gangadhar B Belavadi, HOD of Paediatrics, BMCRI.

14

a) A Multinational, Multicenter, Randomized, Double-blind study Comparing the Efficacy and Safety of AVE5026 with Placebo for the Extended Prevention of Venous Thromboembolism in Patients having Undergone Hip Fracture Surgery.
b) A Multinational, Multicenter, Randomized, Double-blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery – Dr.P.K.Raju, Asst.Prof. of Orthopaedics, BMCRI.

15

A randomized, eight week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (300/5 and 300/10 mg) in comparison with aliskiren 300 mg monotherapy. – Dr.K.M.Veeranna Gowda.M.D., Professor Dept. of Medicine, BMCRI.

16

Protocol No.:2-001: A Randomized Double-Blind, Placebo-Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of Art-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation. – Dr. M.K. Ramesh, Prof. of Surgery, & Dr.Raveendra K.R., Asst. Prof. of Medicine BMCRI. (Combined study)

17

Efficacy, Safety and Tolerability of Fixed Dose combination of Levodraopropizine and Chlorpheniramine Maleate in the treatment of Non Productive Cough – Dr.Raveendra K.R., Asst.Prof. of Medicine, BMCRI.

18

Randomized, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, dose-finding study of Lu AA24530 in Major Depressive Disorder. - Dr. H. Chandrashekhar, Prof.  & HOD of Psychiatry.

19

A Randomized, Placebo-controlled study to evaluate the efficacy, safety and tolerability of CP-533,536 in subjects with closed fracture of the Tibial Shaft (Protocol No.A3241010) - DR.K.V.Puttakemparaju, Asst. Prof. of Orthopaedic, BMCRI.

20

Correlation between the clinical manifestations with the immunological Parameters in H.I.V infected Symptomatic Patients in Tertiary care Hospital in South India under the guidance of Dr. Asima Banu, Asst. Prof. of Microbiology
- Ms. Savitha.S.A, II MBBS student of  BMCRI

21

A 12 week treatment, multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of Indacaterol (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease (COPD) - Dr.K.M.Veeranna Gowda.M.D., Professor Dept. of Medicine,BMCRI.

22

A phase III, 26-week multi-center randomized double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease (COPD) - Dr.C.Nagaraj, Prof. &HOD of Pulmonary Medicine, BMCRI.

23

A 12 week treatment, multi center, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of indacaterol (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease (COPD) - Dr.C.Nagaraj, Prof. &HOD of Pulmonary Medicine, BMCRI.

24

A randomized, eight week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (300/5 and 300/10 mg) in comparison with aliskiren 300 mg  in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy. – Dr.K.M.Veeranna Gowda.M.D., Professor Dept. of Medicine,BMCRI. (Members are requested to bring the protocol on the day of meeting as it was already circulated in the previous meeting).

25

Efficacy, Safety and Tolerability of Fixed Dose combination of Levodraopropizine and Chlorpheniramine Maleate in the treatment of Non Productive Cough – Dr.Raveendra K.R., Asst.Prof. of Medicine, BMCRI. (Members are requested to bring the protocol on the day of meeting as it was already circulated in the previous meeting).

26

A Randomized, Placebo-controlled study to evaluate the efficacy, safety and tolerability of CP-533,536 in subjects with closed fracture of the Tibial Shaft (Protocol No.A3241010) - DR.K.V.Puttakemparaju, Asst. Prof. of Orthopaedic, BMCRI.

27

A Phase I/II study to evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis - Dr. Leelavathi, Asst. Prof. of Dermatology.

28

A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 2 – 8 mg in the Treatment of Major Depressive Disorder with Subjects who are Partial Responders or Non-Responders to Citalopram Therapy –  Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

29

A Phase 3 Randomized, Placebo- and Active Comparator Drug-Controlled Clinical Trial to study the Safety and Efficacy of Administering Two Doses of Lurasidone HCI to Patients Acutely Psychotic with Schizophrenia. Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

30

A prospective, multicenter, double – blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NWL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults – Dr.M.K.Ramesh, Prof. of Surgery, BMCRI.

31

A randomized, double-blind, plcebo-controlled, multicenter, Phase 3 study of drotrecogin alfa (activated) administered as a continuous 96-hour infusion to adult patients with septic shock- Dr.M.K.Ramesh, Prof. of Surgery and Dr.K.R.Ravindra, Asst.Prof. of Medicine (combined study)

32

A Phase I/II study to evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis - Dr. Leelavathi, Asst. Prof. of Dermatology.

                

33

A Phase 3 Randomized, Placebo- and Active Comparator Drug-Controlled Clinical Trial to study the Safety and Efficacy of Administering Two Doses of Lurasidone HCI to Patients Acutely Psychotic with Schizophrenia. Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

34

A Multinational, Multicenter, Randomized, Double-blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing major Abdominal Surgery - Dr.M.K.Ramesh, Prof. of Surgery.

35

A prospective, multicenter, double – blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NWL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults – Dr.M.K.Ramesh, Prof. of Surgery, BMCRI.

36

Air Pollution and Respiratory Morbidity in BangaloreDr.R.Premalatha, Prof. of Paediatrics, BMCRI

37

A randomized, double-blind, plcebo-controlled, multicenter, Phase 3 study of drotrecogin alfa (activated) administered as a continuous 96-hour infusion to adult patients with septic shock- Dr.M.K.Ramesh, Prof. of Surgery and Dr.K.R.Ravindra, Asst.Prof. of Medicine (combined study)

38

A Phase I/II study to evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis - Dr. Leelavathi, Asst. Prof. of Dermatology.

39

A Phase 3 Randomized, Placebo- and Active Comparator Drug-Controlled Clinical Trial to study the Safety and Efficacy of Administering Two Doses of Lurasidone HCI to Patients Acutely Psychotic with Schizophrenia. Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

40

A Multinational, Multicenter, Randomized, Double-blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing major Abdominal Surgery - Dr.M.K.Ramesh, Prof. of Surgery.

41

A prospective, multicenter, double – blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NWL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults – Dr.M.K.Ramesh, Prof. of Surgery, BMCRI.

42

A randomized, double-blind, plcebo-controlled, multicenter, Phase 3 study of drotrecogin alfa (activated) administered as a continuous 96-hour infusion to adult patients with septic shock- Dr.M.K.Ramesh, Prof. of Surgery and Dr.K.R.Ravindra, Asst.Prof. of Medicine (combined study)

43

A Phase I/II study to evaluate the Safety and Efficacy of anti-CD6 monoclonal antibody (T1h mAb) in Patients with Active Psoriasis - Dr. Leelavathi, Asst. Prof. of Dermatology.

                

44

A Phase 3 Randomized, Placebo- and Active Comparator Drug-Controlled Clinical Trial to study the Safety and Efficacy of Administering Two Doses of Lurasidone HCI to Patients Acutely Psychotic with Schizophrenia. Dr. H. Chandrashekhar, Prof. & HOD of Psychiatry.

45

A Multinational, Multicenter, Randomized, Double-blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing major Abdominal Surgery - Dr.M.K.Ramesh, Prof. of Surgery.

46

A Multi-center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing 0.3% Adapalene Topical Gel (Actavis Mid-Atlantic LLC) To Differin (0.3% Adapalene Topical Gel) (Galderma Laboratories, L.P.) And both Active Treatments to A Vehicle Controal (Actavis Mid-Atlantic LLC) In the Treatment of Mild to Moderate Acne Vulgaris. – Dr. H.V.Nataraja, Prof. & Dr.Leelavathy, Asst.Prof. of Dermatology, BMCRI.

47

“A Randomized, Double-Blind, Multicenter, Placebo-controlled, Phase III Superority Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Placebo Ointment Applied Twice Daily for 5 in the Treatment of Adult and Pediatric Subjects with Secondarily-Infected Traumatic Lesions”– Dr.M.K.Ramesh, Prof. of Surgery, BMCRI

48

A phase III, 26-week multi-center randomized double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease (COPD) - Dr.C.Nagaraj, Prof. &HOD of Pulmonary Medicine, BMCRI.

49

A phase III, 12-week multi-center randomized double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (150 and 300 ug o.d.) in patients with chronic obstructive pulmonary disease (COPD) - Dr.Veeranna Gowda, Prof. of Medicine, BMCRI

                

 

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