FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/001438 [Registered on: 15/11/2010]
Last Modified On: 09/10/2014
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study
Modification(s)  
Drug 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
A clinical trial to study the effects of two drugs Olmesartan and metoprolol in patients with high blood pressure and heart disease 
Scientific Title of Study
Modification(s)  
To evaluate the safety and efficacy of fixed dose combination of Olmesartan and Metoprolol succinate ER in hypertensive patients with Cardiovascular Disease (CVD). 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
GPL/Olmax-M/0810/v 01; 25th August 2010  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Prof Dr JC Mohan  
Designation  Director and Chief of Cardiology  
Affiliation  President of the Indian Society of Interventional Cardiology 
Address  Ridge Heart Centre, Sunder Lal Jain hospital, Ashok vihar, Phase III, Delhi-52
Nil
New Delhi
DELHI
110052
India 
Phone  9811061392  
Fax    
Email  jcmohan@vsnl.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Prof Dr JC Mohan  
Designation  Director and Chief of Cardiology 
Affiliation  President of the Indian Society of Interventional Cardiology 
Address  Ridge Heart Centre, Sunder Lal Jain hospital, Ashok vihar, Phase III, Delhi-52
Nil
New Delhi
DELHI
110052
India 
Phone  9811061392  
Fax    
Email  jcmohan@vsnl.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Prof Dr JC Mohan  
Designation  Director and Cheif of Cardiology 
Affiliation  President of the Indian Society of Interventional Cardiology 
Address  Ridge Heart Centre, Sunder Lal Jain hospital, Ashok vihar, Phase III, Delhi-52
Nil
New Delhi
DELHI
110052
India 
Phone  9811061392  
Fax    
Email  jcmohan@vsnl.com  
 
Source of Monetary or Material Support
Modification(s)  
Glenmark Pharmaceuticals Limited, Glenmark Pharmaceuticals Limited (GPL) Corporate Enclave, B. D. Sawant Marg, Chakala, Andheri (E), Mumbai - 99  
 
Primary Sponsor
Modification(s)  
Name  Glenmark Pharmaceuticals Limited  
Address  Corporate Enclave, B. D. Sawant Marg, Chakala, Andheri (E), Mumbai - 99  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  
  India  
Sites of Study
Modification(s)  
No of Sites = 100  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. A K Basu   1, main Road (E), New barrack pore, 24 PGS(N) pin: 700 131  ,-

 
9830059952

asish_basu@rediffmail.com 
Dr. Anup Das Biswas  116, CIT Road, Kolkata- 700014  ,-

 
9830022609

anup.dsbiswas@gmail.com 
Dr. Masood Batin  16, Zakaria Street, Kolkata 73  ,-

 
9831066802

batinmasood@gmail.com 
Dr. Paramartha Bhattacharya   18, Thakur Das babu Lane, PO Behrampore (WB) Dist hooshly 712201  ,-

 
9231851660

parambhat@msn.com 
Dr. Tapas Chatterjea   21 A-10, Ganguli paralane, kolkata 700 002  ,-

 
9830041585

tapas.chaterjea@gmail.com 
Dr. G. K .M Markandeya Rao   35-68, G.K Colony Bus stop, Neredmet 'X' roads, sainikpuri, Secunderabad-094  ,-

 
9989398549 / 040- 27110491

 
Dr. Vijay Mandora   501-B, Ghorpade peth, Panna Chambers, Swargate Corner, Pune- 42  ,-

 
9822345577 / 020- 24471574

mandoravp@yahoo.co.in 
Dr. Curush Kohiar  658, Khorshed-Abad, Gr. Floor, Katrak Road, opp wadala Market, Dadar Mumbai 400014  ,-

 
9820139089 / 022- 24102226

 
Dr. Kajal Ganguly   68B,A K Point Clinic, APC Road, Rajabazar Tram depot, Kolkata 700 009  ,-

 
9830087582/ 9831118148

 
Dr. Kaushik Das   78, Shri ram, Dhang Road, Salkia, Howrah- 711106  ,-

 
9331047123/ 9831458778

drkaushikdas1@hotmail.com 
Dr. Saurabh Mukhopadhyay   8/D, Shyama prasad Mukharjee road, Bhowanipore, kolkata 25  ,-

 
9831360181 / 033- 24551748

drsaurabh220170@rediffmail.com 
Dr. Suhas Erande   Akshay Hospital, opp SNDT College, Near State bank of India, karve Road, Pune 411004  ,-

 
9822025149 / 020- 25431175/ 66023890

drsse@rediffmail.comdrsuhas.erande@gmail.com 
Dr. Tirthaukar Chaudhury  Apollo clinic, Prince Anwar Shah Road, Opp South City Mall, CIT Scheme- 114 B, Kolkata 700045  ,-

 
9831322394 / 033- 40212525

tchaudhury67@yahoo.co.uk 
Dr K Jayaraman   Apollo Family Clinic, Kumaran Colony main Road, Vadapalani, Chennai - 600 026  ,-

 
9841768658 / 044-23632990,23632490

drjayaraman.krishnan@gmail.com 
Dr Sharad Deshmukh  Ashwini Clinic  West High Court Road, Dharampeth, Nagpur- 10
Nagpur
MAHARASHTRA 
9890190690

dr_sndeshmukh@yahoo.com 
Dr Jyoti Barokar  Avanti Heart institute  Department of Cardiology, 5, Abhyankar Road, Dhantoli, Nagpur
Nagpur
MAHARASHTRA 
9823084037
--
jbarokar@hotmail.com 
Dr Poonam Lavhe  Avanti Heart Institute  Department of Cardiology, 5, Abhyankar Road, Dhantoli, Nagpur
Nagpur
MAHARASHTRA 
9850235284
--
pons_gmc@yahoo.com 
Dr. R.K. Lalwani  Batra Hospital, 1,Tughlakabad Institutional Area, M. B. Road, New Delhi-110062  ,-

 
9810066462 / 011- 29958747 Extn 2052

drrklalwani@gmail.com 
Dr VM Bhalerao  Bhalerao Nursing Home  Department of Cardiology, 494, behind kalpana Bldg, Ramdapeth, Nagpur- 10
Nagpur
MAHARASHTRA 
9823083499

vivek_bhalerao@yahoo.com 
Dr Pankaj Harkut  Care Hospital  3, Farmland, Panchsheel Square, Nagpur- 440010
Nagpur
MAHARASHTRA 
9372723376

pankajharkut@rediffmail.com 
Dr Ramrao Ghodeswar  Care Hospital  Department of Cardiology, Ramdaspeth, nagpur
Nagpur
MAHARASHTRA 
9823262625

rmgodeswar@rediffmail.com 
Dr. Nikhil Sahani  Centre for Preventive cardiology, 15&16, Hermes Kunj, Mangaldas Road, Pune 411 001  ,-

 
9325022333 020- 26050077/ 26053344

cpindia@hotmail.com; doctor@cpc.ind.in 
Dr BV Mohan Sundar   Clinic, 127, Bricklin Road, Otteri, Chennai -12  ,-

 
9941315000

bvms.shan@rediffmail.com 
Dr V Parthasarathy   Clinic, No. 9, Venu Reddy Street, Guindy, Chennai - 600 032  ,-

 
9841384499 / 044 - 22345171, 28254305

dparthasarathy@rediffmail.com 
Dr B R Shivkumar  Cosmopolitan Medical Centre  Department of Cardiology, Room No.8, V Main Mariappa Town post, Bangalore 560084
Bangalore
KARNATAKA 
08025790735

dr_shiva_kumar@yahoo.co.in 
Dr Aziz Khan  Crescent Hospital and Heart Centre   Near Lokmat Square, Dhantoli, nagpur- 12
Nagpur
MAHARASHTRA 
9823171959

khanaziz@yahoo.com 
Dr Deepak Jeswani  Criticare Hospital  Dept of Cardiology, Dhantoli, Nagpur
Nagpur
MAHARASHTRA 
9823939000

deepakjeswani2@yahoo.co.in 
Dr Girish Deshpande  Dande Hospital  Department of Cardiology,Ravi Nagar Square, Nagpur- 12
Nagpur
MAHARASHTRA 
9823019091

gcdeshpande1966@gmail.com 
Dr Vishwas Dashputra  Dashputra Nursing Home   37, Arunoday Apartments, Ramkrishna Nagar, Khamla Road, Nagpur 440015
Nagpur
MAHARASHTRA 
9822577723

vishwasdashputra@gmail.com 
Dr. A.G. Veer   Dhanvantari Hospital, Agarwal towers, Hadapsar, Pune- 411 028  ,-

 
9422032876 020- 26999845/ 64001079

dragveer@yahoo.in  
Dr. M L Bhansali   Diabetes & Heart Clinic, 1/1 Hardat Rai Chamaria Road, Howrah  ,-

 
9831093682

drmlbhansali@gmail.com 
Dr Gira Soni  Diabetes and Obesity Clinic  Soni Hospital, Opp. Daga Hospital, Gandhibag, Nagpur- 2
Nagpur
MAHARASHTRA 
9970183632

girasoni27@yahoo.com 
Dr P SelvaKumar   Diabetes Medicaal Centre, No. 3/26, Pulla Avenue, Shenoy nagar, Chennai - 600030  ,-

 
9444414253 / 044-26281819, 42183004

selvakumar@doctor.com 
Dr. P. Raghuramulu   Diabetic centre, h. no.7-1-621/552/10, Opp TB hospital, S. R. Nagar, hyderabad- 500038  ,-

 
9440054211 / 040- 23715070

drpraghu@rediffmail.com 
Dr Jagdish Shah  Dr Shahs Hospital  Sani Shopping Centre, Jogeshwari (W), Mumbai- 400102
Mumbai (Suburban)
MAHARASHTRA 
9869031354

drjnshah@yahoo.com 
Dr. Sandeep Banga  Dr. Banga Heart Care & Ultrasound Clinic, A4/62, Ground floor, Paschim Vihar, new delhi-63  ,-

 
9811155750

drsandeepbanga@hotmail.com 
Dr. Nandkumar Chonkar  Dr. Chonkar's Cardiac Clinic & Damayanti Health Care Pvt. Ltd., Sumati Niwas, Panch Rasta, Behind Saraswat Bank, Mulund (W), Mumbai 400080  ,-

 
9821042031 / 022- 25906524/25686292

chonkar@bom5.vsnl.net.in 
Dr. Harish Takkar   Dr. Takkars Clinic, M-2, 1st floor Kalkaji new delhi 110019  ,-

 
9810427622 / 011- 26437658/ 26437656

htakkar1950@yahoo.com 
Dr GN Shirbur  Enhanced Health Care  212/A, Off. Indiranagar,, 100 Feet Road, 1st main Road, Domlur II Stage, Bangalore 560071
Bangalore
KARNATAKA 
9448994495

gnshirbur@gmail.com 
Dr. (Mrs) H.R. Salkar  Everest Tower, Umred Road, Shakkardara Square, Nagpur 441203  ,-

 
9373289396 / 0712- 2021575

rgsalkar@rediffmail.com 
Dr. Naresh Shetty   Evershine Nursing Home, Evershine Nagar, Saibaba Park, Marve Link road, malad (W), Mumbai-64  ,-

 
9821136548 / 022- 28823903/ 28822079/ 28821828

nareshshetty@yahoo.com 
Dr. Faraz Farishta   Farishta Diabetic Centre, Chirag Ali Lane, Abids, Hyderabad  ,-

 
9885035977 / 040- 66755859

 
Dr. Shashikant Aggarwal   Gautam polyclinic, 9A, K K Tagore Street, kolkata 700 089  ,-

 
9830050510

agarwalshashi25@yahoo.co.in 
Dr. Nilesh Gautam  Gautam's Clinic, Sujata, Flat no.2, 1st Floor,, Opp Police Station, Santacruz (w), Mumbai 400054  ,-

 
9821381097 / 022- 26607752

rinigautam@hotmail.com 
Dr. Shyam Godani  Godani Multispeciality Hospital, Near Indora Police Chowki, Kamptee Road, Nagpur- 440017  ,-

 
9372468608/9850300961

shyamgodani@yahoo.com 
Dr.Sudhindra D   Green View Medical Centre, HSR Layout, Sector V, Off Agara lake, bangalore-34  ,-

 
9845136102 / 080- 25633563

doc_sudhi@yahoo.com 
Dr. Arun Kamble  Healthcare & Dental Clinic, 1st floor, Parmar Villa-1, Wanawadi, Pune 411040  ,-

 
020- 26856166

dr_arunkamble18@yahoo.co.in 
Dr. Umesh Akkalkotkar   Heart care, Samarth Hospital, Archana Apartments, near Manohar Cloth Centre, Near Hadapsar Flyover, Pune 411 028  ,-

 
9823115722 / 020- 26830539

noopuresh@yahoo.co.uk 
Dr H Siddappa  Heart Disease Detection Centre  65, Appareddy Palya, Next to Department of Cardiology, ESI Nurse quarters, Double road, indiranagar, Bangalore-560038
Bangalore
KARNATAKA 
9844141526

drsiddappah@gmail.com 
Dr. Mohammad Samiuzzaman   Heart Line Cardiology Clinic & Research Centre, 10-2-317/14, Near HP gas Godown, Vijay nagar Colony, Hyderabad  ,-

 
09885031480/ 9985908065 / 040- 23343148

drsamicardio@yahoo.com 
Dr K S S Bhat  Heart Lung Clinic  736, CMH Road, Indiranangar, bangalore- 560038
Bangalore
KARNATAKA 
9902537235

ksbhat@gmail.com 
Dr. Chetan Shah   Heart Rhythm Clinic, 3rd floor, Manu Market, Next to Kapol Wadi, M. G. Road, Ghatkopar (W), Mumbai 400086  ,-

 
9821115485 / 022-25133676/ 3881/ 25164438

chetanshah@hotmail.com 
Dr. Nilesh Padhiyar  J.P. Hospital & ICU, J.P. House, Sakinaka, Mumbai- 400072  ,-

 
9821727355

nilesh.padhiyar@rediffmail.com 
Dr.T. Suresh. Row  Jasleen Hospital, Wardha Road, Nagpur- 440012  ,-

 
9422505397 / 9373770269 / 0712- 2422663/2424305

 
Dr.B. Balaji   Jayakrishna Hospital, Raman Thapur, hyderabad ( AP)  ,-

 
9949469695 / 040- 65505956

 
Dr. Susovan Halder  Kasturi Nursing Home, Thakurpukur, 3/A, Bus Stand Kolkata 700063  ,-

 
9831722267 / 033- 24676870/ 2609/ 6418

susovan_1967@yahoo.co.in 
Dr.Rajesh Shavi   Kaveri Speciality Hospital, Hosur Main road, Madiwala, bangalore 68  ,-

 
9845002501 / 080- 25537036/ 22903975

rajschavi@yahoo.co.in 
Dr. Shankar Khobragade  Khobragade Hospital, indora Chowk, kamptee Road, Nagpur- 440017  ,-

 
9823177661

khobragadehospital@gmail.com 
Dr Vaibhav Mistry  Kiran Care and Cure Hospital  Mistry Complex, Sankalp, Nr. Greater Bank, J.B. Nagar, Andheri (E), Mumbai 400059
Mumbai (Suburban)
MAHARASHTRA 
9820134683

vaibhavmistry@hotmail.com 
Dr RS Muralidharan   KS Hospital, 747, Poonamallee High Road, Chennai - 600 010  ,-

 
9444453938/ 9444493192 044-26412326, 26412960

rsmd.stanley@gmail.com 
Dr Jay Deshmukh  Medical nursing Home  Ramdaspeth, Nagpur- 12
Nagpur
MAHARASHTRA 
9822200308

drjaymdeshmukh@yahoo.com 
Dr Kapil Rathi  Medicare Hospital  Dept. of Medicine, Marol Naka Junction, Andheri (E), Mumbai 400059
Mumbai (Suburban)
MAHARASHTRA 
9967646537

drkapilr@yahoo.co.in 
Dr. Sanjeeva Gupta   MGS Hospital & Heart Institute, West punjabi Bagh, New delhi 110024  ,-

 
9312511424

sanjeeva_gupta@rediffmail.com 
Dr. Ajit Kr Satpati   Mitali clinic, Kalyani, Nadia  ,-

 
9830631106

ak.satpati@medicasynergie.in 
Dr Gunasekaran   Mohan Hospital, CP 50, Razack Garden, MMDA Main Road, Arumbakkam, Chennai - 600106  ,-

 
9840437526 / 044-23632990,23632490

gunas12345@hotmail.com 
Dr. Nagraj Desai   Namana Medical Centre, 4/A, Seenappa Layout, off New BEL Road, RMV 2nd Stage, Bangalore- 560094  ,-

 
9845132637 / 080- 65627833, 23518833

namanamedicalcentre@gmail.com 
Dr. Govind Nerlekar  Nerlekar's Clnic, 966-B, Kusalkar Road, pune 411 016  ,-

 
9822032325 / 020- 26346981

sgn47@hotmail.com 
Dr C Vasanth   Nirmal Clinic, 95 (48) TP Koil Street, Triplicane, Chennai - 600 005.  ,-

 
9841186553 / 044 - 65191801

shanthi118@hotmail.com; drcvasanth@gmail.com 
Dr. Shalima Gautam  Om Polyclinic, 1, Umiya Bhuvan, Dr. R.P. Road, Mulund(W), Mumbai 400080  ,-

 
9819185402 / 022- 25910202

shalima16@rediffmail.com 
Dr Mahantesh Charantimath  Panacea Hospital Pvt ltd  Department of Cardiology, 334, 8th main, III stage, IV block, Basaveshwaranagar, Bangalore- 560079
Bangalore
KARNATAKA 
9448462883

mahanteshrc67@gmail.com 
Dr. Dhiren Shah   Pradip Polyclinic, A/4 Khalakdina Terrace, 73, Gowalia tank road, Oopp Warden chemist, mumbai 400036  ,-

 
9820000570 / 022- 23883311/ 23803322

drs1955@hotmail.com 
Dr Chandrakant B Patil   Private Clinic  ANJANADRI, H. No. 26/1, 2nd main road, 3rd Cross, infront of Arun Studio, Chamarajpet, Bangalore 560018
Bangalore
KARNATAKA 
9845014311

drcbpatil@gmail.com 
Dr Ramesh Mundle  Private Clinic  203, Neetigaurav Complex, CB Road, Ramdaspeth, nagpur- 12
Nagpur
MAHARASHTRA 
9822232269

rameshmundle@gmail.com 
Dr. V. S. Ramchandra   Ram heart Care Centre, Below Andhra Bank, Miyapur, Hyderabad  ,-

 
9949033315

ramheart@gmail.com 
Dr.B.R.Venkatesh   Republic Hospital, 5, Langford Gardens, Bangalore- 560025  ,-

 
9448052386

veerannakm@gmail.com 
Dr. J C Mohan   Ridge Haert Centre, Sunder Lal Jain hospital, Ashok vihar, Phase III, Delhi-52  ,-

 
9811061392

jcmohan@vsnl.com 
Dr Ravikumar V N  RMV Hospital  138, AECS Layout, Sanjaynagar, Bangalore 560094
Bangalore
KARNATAKA 
9448718784

ravikumar@gmail.com 
Dr. Omprakash Singh   S.V Diabetic Centre, Astalaxmi Temple Road, Margadarshi Colony, Kothapet, hyderabad- 500035  ,-

 
9392480341 / 040- 24036587

opchowhan@yahoo.com 
Dr. Atin Saha   Saha hospital, C/34, Gurunanak Soc., Kopri, Thane(E) 603  ,-

 
9820042453 / 022- 25323265

saha_hospital@yahoo.com 
Dr. Nilesh Kulkarni   Sai Medicare hospital& Diabetes Care centre, highway Corner, warje, pune 411 058  ,-

 
9822523300 / 020- 25233000

dr.ngkulkarni@gmail.com 
Dr. Anil Sharma  Sanjeevani Hospital, Bhavani Chambers, Kedarmal Road, Malad (E), Mumbai- 97  ,-

 
9820071077

dranilheart@yahoo.co.in 
Dr. Narayan Gadkar  Savla Polyclinic, 176-B, Thank God Building, Near Chembur Post Office, Dr.Sandhu Marg, Chembur, Mumbai- 400071  ,-

 
9820538132 022- 25276158/ 25231313

nggadkar@yahoo.co.in 
Dr. Sanjay Jain  Shantimohan Hospital, 1st floor, Opp. Saraf chambers, Mount road, Sadar, nagpur- 01  ,-

 
9823034085 / 0712- 2542094/ 2553454/ 2541086

sanjay2d@rediffmail.com 
Dr. Suren Chavan   Shraddha Hospital, 41, Tulshibagwale Colony, Sahakarnagar-2, Pune 411009  ,-

 
9822014442 / 020- 24226267

dr.surenchavan@gmail.com 
Dr. Prakash Khetan  Shravan Hospital, nandanwan Main Road, Nagpur- 440009  ,-

 
9823071748 / 0712- 2711737

prakashkhe@gmail.com 
Dr. Anuj Sarda  Shrikrishna Hrudayalaya, Congress Square, Nagpur- 440012  ,-

 
9823048449

sardaaanuj@yahoo.co.in 
Dr. V. Srinivas   Sparsh Diabetic Centre, opp Indo english High School, Santosh Nagar, Hyderabad 500059  ,-

 
9849734964

sn_vut@yahoo.co.in 
Dr. Naresh Kumar Goyal   Speciality Clinic, saraswati vihar, in front of Sarad diagnostics, Pitam pura, New delhi.  ,-

 
9810331109

nkg71@yahoo.com 
Dr. Subhash Saini   Sri Action Heart Centre, FC-34, A-4, Paschim Vihar, new delhi- 110063  ,-

 
9868118828 011- 42888888/ 45666666/ 25274123-7

drsubhashsaini@yahoo.co.in 
Dr Rangaraj  Sri jaydeva institute of Cardiology  Bannerghatta Main Road, Near-Department of Cardiology, Jayadev Hospital, Jayanagar 9th Block, Bengaluru, Karnataka 560069
Bangalore
KARNATAKA 
9845034436

rngram@gmail.com 
Dr. G. N Srinivas   Srinivasa clinic, Shopno. 4, MPR Complex, Shapur Nagar, hyderabad-55  ,-

 
9290437984

gns1969@sify.com 
Dr. Debasis Basu   Sugar- Apollo clinic, 48/1F, Leela Roy Sarani, Gariaghat Road, kolkata 19  ,-

 
9831256908

drdbasu@yahoo.com 
Dr. Margam Kiran Kumar   Sun City Nursing Home, Near Narsimha Swamy Temple, Hydershakote, Hyderabad-8  ,-

 
9849330213 / 040- 64557319

margamkumar@yahoo.com 
Dr. P.P. Deshmukh  Super Speciality Hospital, Tukdoji Square, Nagpur-03  ,-

 
9823057346

pradeepti2001@yahoo.com 
Dr. K. M. Veeranna Gowda   Victoria hospital, Bangalore  ,-

 
9448052386

veerannakm@gmail.com 
Dr P Senthil Kumar   Vishnu Clinic, BB Road, Vyasarpadi, perambur, Chennai - 600039  ,-

 
9884458387

senthil.k.ponnaiah@gmail.com 
Dr. Soura Mookerjee  Welkin Clinic, Garia Station Road, Kolkata- 84  ,-

 
9051363845

drdoura@yahoo.co.in 
Dr. K. C. Kedia   Westend Clinic, 13, Vivekanand aroad, Kolkata 700006  ,-

 
9830053442

kck.kol@gmail.com 
Dr Ajay Sakhare  Wokhardt hospital  Department of Cardiology, 27, Corporation Colony, North Ambazari Road, Gandhinagar, Nagpur 440033
Nagpur
MAHARASHTRA 
9890073614

sakhare_ajay04@rediffmail.com 
Dr Pramod Mundra  Wokhardt hospital  Department of Cardiology, 27, Corporation Colony, North Ambazari Road, Gandhinagar, Nagpur 440033
Nagpur
MAHARASHTRA 
9823026651

pramod_mundra@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
League Health Independent Ethics Committee, Mumbai ( blanket Approval for all the sites and PIs)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Hypertension with Cardiovascular Disease 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Olmax-M [Olmesartan (20mg) and Metoprolol succinate ER (25mg)] Tablet and Olmesartan (20mg) and Metoprolol succinate ER (50mg) Tablet  Olmax-M [Olmesartan (20mg) and Metoprolol succinate ER (25mg)] Tablet and Olmesartan (20mg) Tablet once daily, orally for 4 weeks.allows for dose escalation, if BP is not controlled, to Olmesartan (20mg) and Metoprolol succinate ER (50mg) Tablet once daily, orally for further 4 weeks. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ? All CVD patients (prior MI, ACS, PCI, CABG) with hypertension

OR

? All CVD patients (prior MI, ACS, PCI, CABG) with Uncontrolled hypertension (BP > 140/90 mmHg for hypertensive patients and BP > 130/80 mmHg for hypertensive patients with Diabetes or renal disease).


 
 
ExclusionCriteria 
Details  ? Not willing to provide written informed consent and comply with the protocol ? Age below 18 years and above 65 years ? Secondary hypertension ? Patients requiring concomitant anti-hypertensive medications other than angiotensin receptor blockers (ARBs) or Metoprolol ? Uncontrolled diabetes mellitus ? Baseline laboratory values outside the clinically acceptable limits ? Pregnant women and lactating mothers ? Females of child bearing age not practicing contraception or not willing to use barrier contraceptive ? Known hypersensitivity to Olmesartan/Metoprolol ? Patients with effort angina more than class II (Drugs like Nitrates, ranolazine or Trimetazidine can be used but not amlodipine or nicorandil). ? Sick sinus syndrome or Atrioventricular block or Heart Failure  
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Magnitude of systolic and diastolic blood pressure reduction from baseline at end of 8 weeks of treatment
Percent of subjects reaching blood pressure target of 140/90 mmHg in hypertensive patients and 130/80mmHg in hypertensive patients with diabetes and renal disease at end of 8 weeks of treatment
 
End of 8 weeks of treatment 
 
Secondary Outcome
Modification(s)  
  
Target Sample Size
Modification(s)  
Total Sample Size="1000"
Sample Size from India="1000" 
Phase of Trial
Modification(s)  
Phase 4 
Date of First Enrollment (India)
Modification(s)  
29/09/2010 
Date of First Enrollment (Global)  27/09/2010 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Brief Summary
Modification(s)  
Study Plan Patients will be recruited based on the inclusion and exclusion criteria. In case of uncontrolled hypertension with base line therapy of diuretics or calcium channel blockers ? 2 weeks ?washout period? would be allowed before initiating the patient on combination. Written ?Informed consent? will be obtained from these patients after a thorough explanation of the study. Each patient will receive copy of ?Informed consent? form and ?Patient information? sheet. Patients will be explained regarding benefits and side effects of the treatment as per the available Prescribing Information. At the first visit (Baseline), detailed history and examination of the patients will be performed. Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness would be assessed. During the second visit (after 4 weeks), Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness would be assessed along with Patient compliance and adverse events. If any adverse events have been reported then the information needs to be entered in the adverse event Initial Notification Form. During the Third visit (after 8 weeks), Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness, Patient compliance and adverse events would be assessed along with Global assessment by Investigator and Patient. If any adverse events have been reported then the information needs to be entered in the Adverse event Initial Notification Form. Blood pressure monitoring: Each center will follow BP assessment with standardized mercury manometer or the calibrated android BP apparatus in the Sitting, Non-dominant arm, BP recording with 5 minutes rest in the sitting posture Average of 2 readings will be taken for baselines levels Simultaneously record pulse rate Record standing BP only in those with postural symptoms 
Close