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CTRI Number  CTRI/2011/06/001818 [Registered on: 21/06/2011] Trial Registered Prospectively
Last Modified On: 24/01/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Trial 
Public Title of Study   Clinical Trial of S-Metoprolol , Atorvastatin and Ramipril combination tablet in the treatment of Hypertension" 
Scientific Title of Study   Clinical Study to assess the efficacy and safety of fixed dose combination of S-Metoprolol, Atorvastatin and Ramipril tablets in hypertension coexisting with hyperlipidemia  
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/2010/SMAR/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand V Tendulkar 
Designation  Manager - Medical 
Affiliation   
Address  Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821019  
Email  Anand.Tendulkar@emcure.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anand V Tendulkar 
Designation  Manager - Medical 
Affiliation   
Address  Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821019  
Email  Anand.Tendulkar@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anand V Tendulkar 
Designation  Manager - Medical 
Affiliation   
Address  Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune

Pune
MAHARASHTRA
411057
India 
Phone  020-39821000  
Fax  020-39821019  
Email  Anand.Tendulkar@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd Pune 
Address  Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Pune MAHARASHTRA 411057 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish P Badadare MD Med   Giridhar Clinic   Oshlya Corner Building,Sukhsagar Nagar-411046 Pune
Pune
MAHARASHTRA 
020-26961911

ashishpb2008@gmail.com 
Dr Indraneel Basu MD Med   Sanjeevani Clinic  B 15/56, Sonarpura, Opposite Gauriya Math, Varanasi
Varanasi
UTTAR PRADESH 
0542-3251524

dribasumd@yahoo.co.in 
Dr Rajeev C Naik MD Med   Ketki Hospital  477, N-3, CIDCO, In fornt of Chate House, Near Kamgar Chowk, Aurangabad
Aurangabad
MAHARASHTRA 
0242-2482902

rajivcnaik@indiatimes.com 
Dr Danait Abhijeet Prakash MD Med   Prakash Hospital  Vishwas Complex, Harpale Bld,,Gadital, Hadapsar-411028 Pune
Pune
MAHARASHTRA 
9373730261

drabhijeetdanait@yahoo.in 
Dr ashish Magdum MDMed DMCardio  Kranti Cardiac Centre  Behind Kranti Clinic, Stand Road, Sangli- 416416
Sangli
MAHARASHTRA 
0233-25307555

ashishmagdum@hotmail.com 
Dr Rajesh P Enadle MD Med   Prabhavati Multispeciality Hospital & Research Centre  Ambejogai Road, Latur-413512
Latur
MAHARASHTRA 
02382-227888

enadle@msn.com 
Dr Mahesh V Padsalge MD Med   Shivam Clinic and Research Centre   Shop No 23, Ambika Shopping Centre,,Sector 8 Nerul-400706 Mumbai
Mumbai
MAHARASHTRA 
022-27719497

drmaheshpadsalge@gmail.com 
Dr Vikas Ratnaparkhe MD Med   Dr Hedgewar Rugnalaya  Garkheda Parisar,Near Gajanan Mandir-431005
Aurangabad
MAHARASHTRA 
0240-2331195

vikas-ratnaparkhe@hedgewar.org 
Dr Shantanu Sengupta MD DNB FASE FCCP  Sengupta Hospital & Research Institute  Ravinagar Square, Nagpur
Nagpur
MAHARASHTRA 
9823570925

senguptasp@gmail.com 
Dr Suresh Gaikwad MBBS MDMed  Dr Gaikwads Critical Care Hospital  31, Reshimbag, Sakkardara Square, Umrer Road, Nagpur - 09
Nagpur
MAHARASHTRA 
0712-2740741

gaikwadhospital@ymail.com 
Dr Sudhir Bhatnagar MD MED   Abhinav Multispeciality Hospital  Kamal Chowk, Naya Nakasha,Nagpur-440017
Nagpur
MAHARASHTRA 
9823148978

drsudhirbhatnagar@gmail.com 
Dr S Balamurugan MB DTCD DNB  Chest Research Centre  2, Janki Nagar Extension, Valasaravakkam,Chennai-600087
Chennai
TAMIL NADU 
044-24865796

dr.s.bala@gmail.com 
DrS SivaRamasubramanian MDMed  Radianz Clinical Services  662, K. K. Nagar, Madurai - 625020
Madurai
TAMIL NADU 
0452-2580991

drsivaramsubramanian.radianz@gmail.com 
Dr J Sangumani MD D Diab  Radianz Clinical Services  662, K. K. Nagar, Madurai- 625020
Madurai
TAMIL NADU 
0452-2580991

jeyaraman.sangumani@gmail.com 
Dr Ajay B Dande MDMed  Dande Diabetes and Heart care Centre, Maternity Home  Bhagwant, 49, Maya Nagar, Behind Hotel Deepali Exceutive, N-2, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA 
0240-2483456

drdande@yahoo.com 
Dr Biswakesh Majumdar  Medicine Research & Diagnostic Pvt. Ltd.  68, Chowanghee Road, Kolkata-700020
Kolkata
WEST BENGAL 
033-22811138

dr_biswakes@yahoo.co.in 
Dr Tulsi Das Bhattacharjee  Nightingale Hospital  11, Shakespeare Sarani, Kolkata-700071
Kolkata
WEST BENGAL 
033-22825377

dr.tulsidas.b@gmail.com 
Dr Rajesh R Deshmane MBBS FCPSMed D Diabetology  Shree Mahalaxmi Diabetis Care Centre  OS-14, Akshar Plaza, Opp Sasane Ground, Main Road, Tarabai Park, Kolhapur-416001
Kolhapur
MAHARASHTRA 
0231-2662345

smdcc_kolhapur@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Dr. Babasaheb Ambedkar Medical Research Societys Ethics Committee, Aurangabad for Dr. Vikas Ratnaparkhe   Approved 
Ethics Committee Dande Diabetes and Heart Care Centre, Maternity Home for Dr Ajay B. Dande   Approved 
Ethics Committee Nightingale Hospital for Dr Tulsi Das Bhattacharjee   Approved 
Ethics Committee Radianz Clinical Services for Dr. J. Sangumani   Approved 
Ethics Committee Radianz Clinical Services for Dr. S. Siva Ramsubramanian  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Abhijeet P. Danait  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Ashish Badadare  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Ashish Magdum  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Biswakesh Majumdar  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Indraneel Basu  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Mahesh Padsalge  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Rajeev C. Naik  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Rajesh P. Enadle  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Rajesh R. Deshmane  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. S. Balamurugan  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Shantanu Sengupta  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Sudhir Bhatnagar  Approved 
Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Suresh B. Gaikwad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with essential hypertension coexisting with hyperlipidemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  S-Metoprolol,Atorvastatin,Ramipril  S-Metoprolol-25/50 mg,Atorvastatin-10mg and Ramipril 5mg given orally once daily for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients with serum LDL-C level more than or equal to 130 mg/dL and triglyceride Level lesser than or equal to 350
mg/dL,Subject willing to give written informed consent and willing to comply with study protocol  
 
ExclusionCriteria 
Details  Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or statins or angiotensin receptor blockers, Subjects with history of secondary or malignant hypertension, Patients with significant known respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with any evidence of cardiac arrhythmia on ECG, Known history of myopathy or rhabdomyolysis with statins, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception,Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, Patients with alcohol or drug abuse, Any condition that, in the opinion of the investigator, does not justify the patientís inclusion in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportation of patients with decrease in diastolic blood pressure by atleast 10 mm hg compared to baseline at the end of study.  After 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in LDL-C Levels as compared to Baseline  After 12 weeks 
Mean reduction in Systolic and Diastolic Blood pressure compared to baseline  After 4, 8 and 12 weeks 
Mean reduction in heart rate compared to baseline  After 4, 8 and 12 weeks 
Mean change in total cholesterol, HDL and triglycerides as compared to baseline  After 12 weeks 
Compliance of Therapy  After 4, 8 and 12 weeks 
Subjects as well as Physicians global assessment about tolerability of drugs  After 12 weeks 
Percent of subjects experiencing any drug related adverse events as evaluated and recorded by the investigator   After 4, 8 and 12 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/06/2011 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary   This multicentric, open label, non-comparative clinical trial is planned to assess efficacy and safety of FDC of S -Metoprolol , Atorvastatin and Ramipril Tablet. in the treatment of hypertension coexisting with hyperlipidemia.Patient satisfying inclusion and exclusion criteria will receive Fixed Dose Combination of S (-) Metoprolo Succinate 50 mg + Atorvastatin 10 mg + Ramipril 5 mg tablet orally once a day. Dose will modified in subsequent visit to S (-) Metoprolo Succinate 25 mg + Atorvastatin 10 mg + Ramipril 5 mg tablet (if BP < 110/75). Baseline laboratory investigations will be done. Patients will be evaluated for efficacy and safety variables after 4, 8 and 12 weeks of therapy. Same laboratory investigations will be repeated after 12 weeks of therapy except ECG. The study duration is of 12 weeks  
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