| CTRI Number |
CTRI/2011/06/001819 [Registered on: 21/06/2011] Trial Registered Prospectively |
| Last Modified On: |
02/11/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of S-Metoprolol and Telmisartan combination tablet in the treatment of hypertension |
|
Scientific Title of Study
|
Clinical trial to assess the efficacy and safety of fixed dose combination of S-Metoprolol and Telmisartan tablets in hypertension |
| Trial Acronym |
SMT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EPL/2010/SMT/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
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
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 |
Survey No. 255/2, Phase I, Rajiv Gandhi IT Park, MIDC, Hinjewadi, Pune-411057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Bhatnagar MDMed |
Abhinav Multispeciality Hospital |
Kamal Chowk, Naya nakasha, Nagpur - 440017
Nagpur
MAHARASHTRA |
0712-2641715
drsudhirbhatnagar@gmail.com |
| Dr S Balamurugan MB DTCD DNB |
Chest Research Centre |
2, First Cross, Janaki Nagar Extension,Valasaravakkam-600087
Chennai
Chennai
TAMIL NADU |
044-24865796
dr.s.bala@gmail.com |
| Dr Ajay B Dande MDMed |
Dande Diabetes and Heart care Centre, Maternity Home |
Bhangwant, 49, Maya nagar, Behind Hotel Deepali Exceutive, N-2, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
0240-2483456
drdande@yahoo.com |
| Dr S K Raut |
Dhanvantari Hospital |
Pune-Solapur Road, Near Gadital, Hadapsar, Pune
Pune
MAHARASHTRA |
9423581029
skcorporate@yahoo.co.uk |
| Dr Suresh Gaikwad MBBS MDMed |
Dr Gaikwads Critical Care Centre |
31, Reshimbag, Sakkardara Square, Umrer Road, Nagpur - 09
Nagpur
MAHARASHTRA |
0712-2740741
gaikwadhospital@ymail.com |
| Dr Ashish Badadare MDMed |
Giridhar Clinic |
Shree Oshiya Corner, In front of Sukhsagar Telephone Exchange, Sukhsagar nagar, Pune-411016
Pune
MAHARASHTRA |
020-26961911
ashishpb2008@gmail.com |
| Dr Rajeev C Naik MDMed |
Ketki Hospital |
Plot No. 477, N-3, CIDCO,Near Kamgar Chowk, In front of Chate House-431003
Aurangabad
Aurangabad
MAHARASHTRA |
0240-2482902
rajivcnaik@indiatimes.com |
| Dr Ashish Magdum MDMed DMCardio |
Kranti Cardiac Centre |
Behind Kranti Clinic, Near Bus Stand, 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 MDMed |
Prabhavati Multispeciality Hospital & Research Centre |
Ambejogai Road, Latur
Latur
MAHARASHTRA |
02382-227111
enadle@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 S SivaRamasubramanian MDMed |
Radianz Clinical Services |
662, K K Nagar, Madurai-625020
Madurai
TAMIL NADU |
0452-2580991
drsivaramsubramanian.radianz@gmail.com |
| Dr Indraneel Basu |
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 |
Ravi Nagar Square, Nagpur
Nagpur
MAHARASHTRA |
9823570925
senguptasp@gmail.com |
| Dr Mahesh Padsalge MDMed |
Shivam Clinic & Research Centre |
23, Ambika Shopping Centre, Sector-8, Nerul, Navi Mumbai-400706
Mumbai
MAHARASHTRA |
022-27719497
drmaheshpadsalge@gmail.com |
| Dr Rajesh R Deshmane MBBS FCPSMed D Diabetology |
Shree Mahalaxmi Diabetis Care Centre |
Os-14, Akshar Plaza, Opposite 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= 17 |
| Name of Committee |
Approval Status |
| 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. Ashish Magdum |
Approved |
| Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr. Ashish P. Badadare |
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 Enadle |
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. S. K. Raut |
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 |
| Independent Ethics Committee, Dhanashree Hospital Navi Sangvi, Pune 411025 for Dr.Rajesh R. Deshmane |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with essential hypertension , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metoprolol 50mg, Telmisartan 20/40 mg |
One tablet of Metoprolo 50 mg and One tablet of Telmisartan 20/40 mg orally once daily for 12 weeks. |
| Intervention |
S-Metoprolol 25 mg, Telmisartan 20/40 mg |
Fixed Dose Combination of S-Metoprolol 25mg and Telmisartan 20/40 mg orally once daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients between 18-65 years of age, Patients diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients willing to give written informed consent and willing to comply with study protocol
|
|
| ExclusionCriteria |
| Details |
Patients previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or angiotensin receptor blockers, Patients with history of secondary or malignant hypertension, Patients with evidence of any cardiac arrhythmia on ECG, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, 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 known 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
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks |
Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline |
After 4, 8 and 12 weeks |
| Reduction in mean heart rate compared to baseline |
After 4, 8 and 12 weeks |
| Compliance to treatment |
After 4, 8 and 12 weeks |
Subject’s as well as Physicians global assessment about the tolerability of the drug
|
After 12 weeks |
| Percent of the subjects experiencing any drug related adverse event 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)
|
30/06/2011 |
| 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, comparative clinical trial is planned to assess efficacy and safety of FDC of S(-) Metoprolol(25 mg) and Telmisartan(20/40 mg) Tablet. Patients stisfing Patient satisfying inclusion and exclusion criteria will receive either Test / Reference drug as per randomization..In Test group patient will receive FDC of S-Metoprolol 25 mg + Telmisartan 20mg and Reference group will receive one tablet of Metoprolol 50mg and Telmisartan 20 mg each. In test group dose will modified in subsequent visit to S-Metoprolol 25mg and Telmisartan 40 mg and in Reference group it will modify upto Metoprolo 50 mg and Olmesartan 40 mg each. (if BP > 140/90). 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 |