| 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 Study |
|
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 |
| Trial Acronym |
SMAR |
|
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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 |
| 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 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 Vikas Ratnaparkhe MD Med |
Dr Hedgewar Rugnalaya |
Garkheda Parisar,Near Gajanan Mandir-431005
Aurangabad
MAHARASHTRA |
0240-2331195
vikas-ratnaparkhe@hedgewar.org |
| Dr Ashish P Badadare MD Med |
Giridhar Clinic |
Oshlya Corner Building,Sukhsagar Nagar-411046
Pune
Pune
MAHARASHTRA |
020-26961911
ashishpb2008@gmail.com |
| 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 ashish Magdum MDMed DMCardio |
Kranti Cardiac Centre |
Behind Kranti Clinic, Stand Road, Sangli- 416416
Sangli
MAHARASHTRA |
0233-25307555
ashishmagdum@hotmail.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 P Enadle MD Med |
Prabhavati Multispeciality Hospital & Research Centre |
Ambejogai Road, Latur-413512
Latur
MAHARASHTRA |
02382-227888
enadle@msn.com |
| Dr Danait Abhijeet Prakash MD Med |
Prakash Hospital |
Vishwas Complex, Harpale Bld,,Gadital, Hadapsar-411028
Pune
Pune
MAHARASHTRA |
9373730261
drabhijeetdanait@yahoo.in |
| Dr J Sangumani MD D Diab |
Radianz Clinical Services |
662, K. K. Nagar, Madurai- 625020
Madurai
TAMIL NADU |
0452-2580991
jeyaraman.sangumani@gmail.com |
| DrS SivaRamasubramanian MDMed |
Radianz Clinical Services |
662, K. K. Nagar, Madurai - 625020
Madurai
TAMIL NADU |
0452-2580991
drsivaramsubramanian.radianz@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 Shantanu Sengupta MD DNB FASE FCCP |
Sengupta Hospital & Research Institute |
Ravinagar Square, Nagpur
Nagpur
MAHARASHTRA |
9823570925
senguptasp@gmail.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 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
|
|
|
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 patient’s 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"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/06/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 |