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 Study
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).
Trial Acronym
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
Phone 9811061392
Fax
Email jcmohan@vsnl.com
Details of Contact Person
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
Phone 9811061392
Fax
Email jcmohan@vsnl.com
Details of Contact Person
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
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)
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
Dr. Anup Das Biswas
116, CIT Road, Kolkata- 700014
,-
9830022609
Dr. Masood Batin
16, Zakaria Street, Kolkata 73
,-
9831066802
Dr. Paramartha Bhattacharya
18, Thakur Das babu Lane, PO Behrampore (WB) Dist hooshly 712201
,-
9231851660
Dr. Tapas Chatterjea
21 A-10, Ganguli paralane, kolkata 700 002
,-
9830041585
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
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
Dr. Saurabh Mukhopadhyay
8/D, Shyama prasad Mukharjee road, Bhowanipore, kolkata 25
,-
9831360181 / 033- 24551748
Dr. Suhas Erande
Akshay Hospital, opp SNDT College, Near State bank of India, karve Road, Pune 411004
,-
9822025149 / 020- 25431175/ 66023890
Dr. Tirthaukar Chaudhury
Apollo clinic, Prince Anwar Shah Road, Opp South City Mall, CIT Scheme- 114 B, Kolkata 700045
,-
9831322394 / 033- 40212525
Dr K Jayaraman
Apollo Family Clinic, Kumaran Colony main Road, Vadapalani, Chennai - 600 026
,-
9841768658 / 044-23632990,23632490
Dr Sharad Deshmukh
Ashwini Clinic
West High Court Road, Dharampeth, Nagpur- 10
9890190690
Dr Jyoti Barokar
Avanti Heart institute
Department of Cardiology, 5, Abhyankar Road, Dhantoli,
Nagpur
9823084037
Dr Poonam Lavhe
Avanti Heart Institute
Department of Cardiology, 5, Abhyankar Road, Dhantoli, Nagpur
9850235284
Dr. R.K. Lalwani
Batra Hospital, 1,Tughlakabad Institutional Area, M. B. Road, New Delhi-110062
,-
9810066462 / 011- 29958747 Extn 2052
Dr VM Bhalerao
Bhalerao Nursing Home
Department of Cardiology, 494, behind kalpana Bldg, Ramdapeth, Nagpur- 10
9823083499
Dr Pankaj Harkut
Care Hospital
3, Farmland, Panchsheel Square, Nagpur- 440010
9372723376
Dr Ramrao Ghodeswar
Care Hospital
Department of Cardiology, Ramdaspeth, nagpur
9823262625
Dr. Nikhil Sahani
Centre for Preventive cardiology, 15&16, Hermes Kunj, Mangaldas Road, Pune 411 001
,-
9325022333 020- 26050077/ 26053344
Dr BV Mohan Sundar
Clinic, 127, Bricklin Road, Otteri, Chennai -12
,-
9941315000
Dr V Parthasarathy
Clinic, No. 9, Venu Reddy Street, Guindy, Chennai - 600 032
,-
9841384499 / 044 - 22345171, 28254305
Dr B R Shivkumar
Cosmopolitan Medical Centre
Department of Cardiology, Room No.8, V Main Mariappa Town post, Bangalore 560084
08025790735
Dr Aziz Khan
Crescent Hospital and Heart Centre
Near Lokmat Square, Dhantoli, nagpur- 12
9823171959
Dr Deepak Jeswani
Criticare Hospital
Dept of Cardiology, Dhantoli, Nagpur
9823939000
Dr Girish Deshpande
Dande Hospital
Department of Cardiology,Ravi Nagar Square, Nagpur- 12
9823019091
Dr Vishwas Dashputra
Dashputra Nursing Home
37, Arunoday Apartments, Ramkrishna Nagar, Khamla Road, Nagpur 440015
9822577723
Dr. A.G. Veer
Dhanvantari Hospital, Agarwal towers, Hadapsar, Pune- 411 028
,-
9422032876 020- 26999845/ 64001079
Dr. M L Bhansali
Diabetes & Heart Clinic, 1/1 Hardat Rai Chamaria Road, Howrah
,-
9831093682
Dr Gira Soni
Diabetes and Obesity Clinic
Soni Hospital, Opp. Daga Hospital, Gandhibag, Nagpur- 2
9970183632
Dr P SelvaKumar
Diabetes Medicaal Centre, No. 3/26, Pulla Avenue, Shenoy nagar, Chennai - 600030
,-
9444414253 / 044-26281819, 42183004
Dr. P. Raghuramulu
Diabetic centre, h. no.7-1-621/552/10, Opp TB hospital, S. R. Nagar, hyderabad- 500038
,-
9440054211 / 040- 23715070
Dr Jagdish Shah
Dr Shahs Hospital
Sani Shopping Centre, Jogeshwari (W), Mumbai- 400102
9869031354
Dr. Sandeep Banga
Dr. Banga Heart Care & Ultrasound Clinic, A4/62, Ground floor, Paschim Vihar, new delhi-63
,-
9811155750
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
Dr. Harish Takkar
Dr. Takkars Clinic, M-2, 1st floor Kalkaji new delhi 110019
,-
9810427622 / 011- 26437658/ 26437656
Dr GN Shirbur
Enhanced Health Care
212/A, Off. Indiranagar,, 100 Feet Road, 1st main Road, Domlur II Stage, Bangalore 560071
9448994495
Dr. (Mrs) H.R. Salkar
Everest Tower, Umred Road, Shakkardara Square, Nagpur 441203
,-
9373289396 / 0712- 2021575
Dr. Naresh Shetty
Evershine Nursing Home, Evershine Nagar, Saibaba Park, Marve Link road, malad (W), Mumbai-64
,-
9821136548 / 022- 28823903/ 28822079/ 28821828
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
Dr. Nilesh Gautam
Gautam's Clinic, Sujata, Flat no.2, 1st Floor,, Opp Police Station, Santacruz (w), Mumbai 400054
,-
9821381097 / 022- 26607752
Dr. Shyam Godani
Godani Multispeciality Hospital, Near Indora Police Chowki, Kamptee Road, Nagpur- 440017
,-
9372468608/9850300961
Dr.Sudhindra D
Green View Medical Centre, HSR Layout, Sector V, Off Agara lake, bangalore-34
,-
9845136102 / 080- 25633563
Dr. Arun Kamble
Healthcare & Dental Clinic, 1st floor, Parmar Villa-1, Wanawadi, Pune 411040
,-
020- 26856166
Dr. Umesh Akkalkotkar
Heart care, Samarth Hospital, Archana Apartments, near Manohar Cloth Centre, Near Hadapsar Flyover, Pune 411 028
,-
9823115722 / 020- 26830539
Dr H Siddappa
Heart Disease Detection Centre
65, Appareddy Palya, Next to Department of Cardiology, ESI Nurse quarters, Double road, indiranagar, Bangalore-560038
9844141526
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
Dr K S S Bhat
Heart Lung Clinic
736, CMH Road, Indiranangar, bangalore- 560038
9902537235
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
Dr. Nilesh Padhiyar
J.P. Hospital & ICU, J.P. House, Sakinaka, Mumbai- 400072
,-
9821727355
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
Dr.Rajesh Shavi
Kaveri Speciality Hospital, Hosur Main road, Madiwala, bangalore 68
,-
9845002501 / 080- 25537036/ 22903975
Dr. Shankar Khobragade
Khobragade Hospital, indora Chowk, kamptee Road, Nagpur- 440017
,-
9823177661
Dr Vaibhav Mistry
Kiran Care and Cure Hospital
Mistry Complex, Sankalp, Nr. Greater Bank, J.B. Nagar, Andheri (E), Mumbai 400059
9820134683
Dr RS Muralidharan
KS Hospital, 747, Poonamallee High Road, Chennai - 600 010
,-
9444453938/ 9444493192 044-26412326, 26412960
Dr Jay Deshmukh
Medical nursing Home
Ramdaspeth, Nagpur- 12
9822200308
Dr Kapil Rathi
Medicare Hospital
Dept. of Medicine, Marol Naka Junction, Andheri (E), Mumbai 400059
9967646537
Dr. Sanjeeva Gupta
MGS Hospital & Heart Institute, West punjabi Bagh, New delhi 110024
,-
9312511424
Dr. Ajit Kr Satpati
Mitali clinic, Kalyani, Nadia
,-
9830631106
Dr Gunasekaran
Mohan Hospital, CP 50, Razack Garden, MMDA Main Road, Arumbakkam, Chennai - 600106
,-
9840437526 / 044-23632990,23632490
Dr. Nagraj Desai
Namana Medical Centre, 4/A, Seenappa Layout, off New BEL Road, RMV 2nd Stage, Bangalore- 560094
,-
9845132637 / 080- 65627833, 23518833
Dr. Govind Nerlekar
Nerlekar's Clnic, 966-B, Kusalkar Road, pune 411 016
,-
9822032325 / 020- 26346981
Dr C Vasanth
Nirmal Clinic, 95 (48) TP Koil Street, Triplicane, Chennai - 600 005.
,-
9841186553 / 044 - 65191801
Dr. Shalima Gautam
Om Polyclinic, 1, Umiya Bhuvan, Dr. R.P. Road, Mulund(W), Mumbai 400080
,-
9819185402 / 022- 25910202
Dr Mahantesh Charantimath
Panacea Hospital Pvt ltd
Department of Cardiology, 334, 8th main, III stage, IV block, Basaveshwaranagar, Bangalore- 560079
9448462883
Dr. Dhiren Shah
Pradip Polyclinic, A/4 Khalakdina Terrace, 73, Gowalia tank road, Oopp Warden chemist, mumbai 400036
,-
9820000570 / 022- 23883311/ 23803322
Dr Chandrakant B Patil
Private Clinic
ANJANADRI, H. No. 26/1, 2nd main road, 3rd Cross, infront of Arun Studio, Chamarajpet, Bangalore 560018
9845014311
Dr Ramesh Mundle
Private Clinic
203, Neetigaurav Complex, CB Road, Ramdaspeth, nagpur- 12
9822232269
Dr. V. S. Ramchandra
Ram heart Care Centre, Below Andhra Bank, Miyapur, Hyderabad
,-
9949033315
Dr.B.R.Venkatesh
Republic Hospital, 5, Langford Gardens, Bangalore- 560025
,-
9448052386
Dr. J C Mohan
Ridge Haert Centre, Sunder Lal Jain hospital, Ashok vihar, Phase III, Delhi-52
,-
9811061392
Dr Ravikumar V N
RMV Hospital
138, AECS Layout, Sanjaynagar, Bangalore 560094
9448718784
Dr. Omprakash Singh
S.V Diabetic Centre, Astalaxmi Temple Road, Margadarshi Colony, Kothapet, hyderabad- 500035
,-
9392480341 / 040- 24036587
Dr. Atin Saha
Saha hospital, C/34, Gurunanak Soc., Kopri, Thane(E) 603
,-
9820042453 / 022- 25323265
Dr. Nilesh Kulkarni
Sai Medicare hospital& Diabetes Care centre, highway Corner, warje, pune 411 058
,-
9822523300 / 020- 25233000
Dr. Anil Sharma
Sanjeevani Hospital, Bhavani Chambers, Kedarmal Road, Malad (E), Mumbai- 97
,-
9820071077
Dr. Narayan Gadkar
Savla Polyclinic, 176-B, Thank God Building, Near Chembur Post Office, Dr.Sandhu Marg, Chembur, Mumbai- 400071
,-
9820538132 022- 25276158/ 25231313
Dr. Sanjay Jain
Shantimohan Hospital, 1st floor, Opp. Saraf chambers, Mount road, Sadar, nagpur- 01
,-
9823034085 / 0712- 2542094/ 2553454/ 2541086
Dr. Suren Chavan
Shraddha Hospital, 41, Tulshibagwale Colony, Sahakarnagar-2, Pune 411009
,-
9822014442 / 020- 24226267
Dr. Prakash Khetan
Shravan Hospital, nandanwan Main Road, Nagpur- 440009
,-
9823071748 / 0712- 2711737
Dr. Anuj Sarda
Shrikrishna Hrudayalaya, Congress Square, Nagpur- 440012
,-
9823048449
Dr. V. Srinivas
Sparsh Diabetic Centre, opp Indo english High School, Santosh Nagar, Hyderabad 500059
,-
9849734964
Dr. Naresh Kumar Goyal
Speciality Clinic, saraswati vihar, in front of Sarad diagnostics, Pitam pura, New delhi.
,-
9810331109
Dr. Subhash Saini
Sri Action Heart Centre, FC-34, A-4, Paschim Vihar, new delhi- 110063
,-
9868118828 011- 42888888/ 45666666/ 25274123-7
Dr Rangaraj
Sri jaydeva institute of Cardiology
Bannerghatta Main Road, Near-Department of Cardiology, Jayadev Hospital, Jayanagar 9th Block, Bengaluru, Karnataka 560069
9845034436
Dr. G. N Srinivas
Srinivasa clinic, Shopno. 4, MPR Complex, Shapur Nagar, hyderabad-55
,-
9290437984
Dr. Debasis Basu
Sugar- Apollo clinic, 48/1F, Leela Roy Sarani, Gariaghat Road, kolkata 19
,-
9831256908
Dr. Margam Kiran Kumar
Sun City Nursing Home, Near Narsimha Swamy Temple, Hydershakote, Hyderabad-8
,-
9849330213 / 040- 64557319
Dr. P.P. Deshmukh
Super Speciality Hospital, Tukdoji Square, Nagpur-03
,-
9823057346
Dr. K. M. Veeranna Gowda
Victoria hospital, Bangalore
,-
9448052386
Dr P Senthil Kumar
Vishnu Clinic, BB Road, Vyasarpadi, perambur, Chennai - 600039
,-
9884458387
Dr. Soura Mookerjee
Welkin Clinic, Garia Station Road, Kolkata- 84
,-
9051363845
Dr. K. C. Kedia
Westend Clinic, 13, Vivekanand aroad, Kolkata 700006
,-
9830053442
Dr Ajay Sakhare
Wokhardt hospital
Department of Cardiology, 27, Corporation Colony, North Ambazari Road, Gandhinagar, Nagpur 440033
9890073614
Dr Pramod Mundra
Wokhardt hospital
Department of Cardiology, 27, Corporation Colony, North Ambazari Road, Gandhinagar, Nagpur 440033
9823026651
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
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
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
End of 8 weeks of treatment
Secondary Outcome
Modification(s)
Target Sample Size
Modification(s)
Total Sample Size= "1000"Sample Size from India= "1000" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)= ""
Phase of Trial
Modification(s)
Phase 4
Date of First Enrollment (India)
Modification(s)
29/09/2010
Date of Study Completion (India) Date Missing
Date of First Enrollment (Global) 27/09/2010
Date of Study Completion (Global) Date Missing
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
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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
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