Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar 2019 06:06:36 GMT) CTRI Number CTRI/2010/091/000514 [Registered on: 25/05/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Single Arm Trial Clinical Study on Fixed Dose Combination of (S)-Metoprolol Succinate and Clopidogrel bisulphate Tablet Clinical Study on Fixed Dose Combination of (S)-Metoprolol Succinate and Clopidogrel bisulphate Tablet Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) EPL/2009/S-METO/CLOP Protocol Number Details of Principal Investigator Dr. Indraneel Basu, MD Sanjeevani Clinic, Opposite Gauria Math, Sonarpura, Varanasi UTTAR PRADESH Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone 09935036063 Fax dribasumd@yahoo.co.in Details Contact Person (Scientific Query) Dr. Onkar Swami, MD Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC,Hinjwadi 411057 Phone 020-39821000 Fax 020-39821019 Onkar.Swami@emcure.co.in Details Contact Person (Public Query) Dr. Onkar Swami, MD Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC,Hinjwadi 411057 Phone 020-39821000 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 020-39821019 > Emcure Pharmaceuticals Ltd. Type of Sponsor NONE List of Countries of Principal Investigator Dr. Suresh Gaikwad, Dr. Vikas Ratnaparkhe, Dr. Ashish P. Badadare, Dr. Rajeev C. Naik, MD (Med) Dr. Shivram Bhonagiri, Dr. Rajesh P. Enadle, Dr. Danait Abhijeet Prakash, Dr. Indraneel Basu, MD (Med) Dr. Mahesh V. Padsalge, Onkar.Swami@emcure.co.in Source of Monetary or Material Support Primary Sponsor Details Emcure Pharmaceuticals Ltd. of Site Site Phone/Fax/ Dr. Gaikwad?s Critical Care Centre, Nagpur Dr. Hedgewar Rugnalaya Giridhar Clinic Ketki Hospital Medipoint Hospital Prabhavati Multi Speciality Hospital and Research Centre, Prakash Hospital Sanjeevani Clinic Shivam Clinic and Research Centre 31, Reshimbag, Umrer road,sakkardara area-440009 Nagpur Garkheda,-431005 Aurangabad BIHAR Oshlya Corner Bulding,Sukhsagar Nagar-411046 Plot No. 477, N-3, CIDCO,Near Kamgar Chowk, Opp. to Chate House-431 003 Aurangabad BIHAR S No. 214/1 Aundh Baner Boundary,Baner- 411007 Ambajogai Road,,-413 512 Latur Vishwas Complex, Harpale Bld,Gadital Hadapsar-411028 Opposite Gauria Math,,Sonarpura,- Varanasi UTTAR PRADESH Shop No 23, Ambika Shopping Centre,,Sector 8 Nerul, 0240-2482902 vijaypathade@gnail.co m enadle@msn.com 09935036063 dribasumd@yahoo.co.i n 02227719497 drmaheshpadsalge@g page 2 / 5
Details of Ethics Committee Dr. Debasis Mitra, MD, DM, FCCP ULTIMUS Clinic -400706 Mumbai GD 302, Salt Lake City, Sut III,-700106 Kolkata WEST BENGAL mail.com of Committee Approval Status Date of Approval Is Committee? Dr. Babasaheb Ambedkar Medical Research Society?s Ethics For Dr. Vikas Ratnaparkhe for Dr. Ashish P. Badadare for Dr. Danait Abhijeet Prakash for Dr. Dr. Debasis Mitra for Dr. Indraneel Basu for Dr. Mahesh Padsalge for Dr. Rajesh P. Enadle for Dr. Rajiv C. Naik for Dr. Shivram Bhonagiri for Dr. Suresh Gaikwad Regulatory Clearance Status Date page 3 / 5
Status from DCGI Not Applicable No Date Specified Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Health Type Condition Type Details Intervention Fixed Dose Combination of S (-) Metoprolol Succinate extended release (25 mg / 50 mg) and Clopidogrel bisulphate immediate release (75 mg) tablet. Comparator Agent NIL NIL Age From Age To Gender Details Details Not Applicable Centralized Open Label Inclusion Criteria Hypertensive patients with ischemic heart disease (IHD) / diabetes mellitus / peripheral vascular disease OR subjects with previous history of myocardial infraction / cerebrovascular accident OR subjects who are at high risk for atherothrombotice events. One tablet to be taken orally once daily 1.Male or female subjects between 40-65 years of age. 2.Subjects with hypertension 3.Subjects with ischemic heart disease (IHD) / diabetes mellitus / peripheral vascular disease OR subjects with previous history of myocardial infraction/ cerebrovascular accident OR subjects who are at high risk for atherothrombotic events 4.Subject willing to give written informed consent and willing to comply with study protocol Exclusion Criteria 1.Subjects previously sensitive to Metoprolol, S-Metoprolol, Clopidogrel, or to any of the ingredients of the fixed dose combination under study. 2.Subjects with Hypertension, requiring antihypertensive therapy other than Metoprolol. 3.Subjects with history of secondary or Malignant Hypertension. 4.Subjects requiring multidrug antihypertensive therapy. 5.Subjects with cardiac arrhythmia or any abnormality on ECG. 6.Patients with significant respiratory/liver/kidney/neurological diseases 7.Patients with active pathological bleeding OR history of bleeding tendencies or bleeding disorders. 8.Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception. 9.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. 10.Patients with Alcohol or drug abuse. 11.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study. Primary Outcome Outcome Timepoints 1) Control of blood pressure 2) Any cardiovascular/ atherothrombotic event Day 0 (screening), day 14, and day 28 Secondary Outcome Outcome Timepoints page 4 / 5
Powered by TCPDF (www.tcpdf.org) Target Sample Size NIL Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=100 Sample Size from = No Date Specified 24/05/2010 Years=0 Months=8 Days=0 Completed This multicentric, open label, non-comparative clinical trial is conducted to assess efficacy and safety of FDC of S (-) Metoprolol Succinate extended release (25 mg / 50 mg) and Clopidogrel bisulphate immediate release (75 mg) tablet in high risk hypertensives who also need anti-platelet therapy. Subjects satisfing exclusion and inclusion criteria will receive test drug orally once daily. Efficacy variable will be control of blood pressure and any cardiovascular/ atherothrombotic event. Safty variables will be Subject?s/Physician?s global assessment about the tolerability of the drug, Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator, and deviation in normal laboratory values/ecg before and after therapy. Subjects will be evaluated at day 0, 14 and 28. NIL page 5 / 5