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1 Clinical Trial Details (PDF Generation Date :- Sun, 17 Mar :52:10 GMT) CTRI Number CTRI/2010/091/ [Registered on: 30/11/2010] - 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-amlodipine besylate and Clopidogrel bisulphate Tablet Clinical Study on Fixed Dose Combination of S-amlodipine besylate and Clopidogrel bisulphate Tablet Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EPL/2009/S-AM/CLOP Designation Affiliation Protocol Number Details of Principal Investigator Dr. Onkar Swami, MD Phone Fax Designation Affiliation Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi Onkar.Swami@emcure.co.in Details Contact Person (Scientific Query) Dr. Onkar Swami, MD Phone Fax Designation Affiliation Emcure Pharmaceuticals Ltd. Emcure Pharmaceuticals Ltd, Rajiv Gandhi IT Park Phase I, MIDC, Hinjwadi 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 page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Emcure Pharmaceuticals Ltd,. Type of Sponsor None List of Countries of Principal Investigator Dr. Sudhir Bhatnagar, MD (MED) Dr. S. Balamurugan, MBBS; DTCD; DNB Dr. Suresh Gaikwad, Dr. Vikas Ratnaparkhe, Dr. Ashish P. Badadare, Dr. Rajeev C. Naik, MD (Med) Dr. Shivram Bhonagiri, Dr. Vikas G. Pai, MD FIACM Source of Monetary or Material Support Primary Sponsor Details Emcure Pharmaceuticals Ltd,. of Site Site Phone/Fax/ Abhinav Multispeciality Hospital Kamal Chowk, Naya Nakasha, Nagpur Chest Research Centre #2, First Cross, Janaki Nagar Extension,Valas aravakkam Chennai TAMIL NADU Dr. Gaikwad?s Critical Care Centre Dr. Hedgewar Rugnalaya Giridhar Clinic Ketki Hospital 31, Reshimbag, Umrer road, Nagpur Garkheda Parisar,Near Gajanan Mandir Not Applicable N/A Oshlya Corner Building,Sukhsagar Nagar Plot No. 477, N-3, CIDCO,Near Kamgar Chowk, Opp. to Chate House Aurangabad BIHAR Medipoint Hospital S No. 241/1 Aundh? Baner,Baner Pai Clinic and Diagnostic Centre Abhinav Aprts, 778/B-1, Shivaji Nagar,Next to Congress House gaikwadhospital@yaho omail.com vikas-ratnaparkhe@hed gewar.org ashishb2008@rediffmai l.com vijaypathade@gmail.co m shivrambona@yahoo.c o.in paivikas@indiatimes.co m page 2 / 6

3 Details of Ethics Committee Dr. Rajesh P. Enadle, Dr. Danait Abhijeet Prakash, Dr. Indraneel Basu, MD (Med) Dr. Mahesh V. Padsalge, Dr. Debasis Mitra, MD, DM, FCCP Prabhavati Multi Speciality Hospital and Research Centre Prakash Hospital Sanjeevani Clinic Shivam Clinic and Research Centre ULTIMUS Clinic Ambajogai Road, Latur Vishwas Complex, Harpale Bld,,Gadital, Hadapsar Opposite Gauria Math, Sonarpura,,- Varanasi UTTAR PRADESH Shop No 23, Ambika Shopping Centre,,Sector 8 Nerul Mumbai GD 302, Salt Lake City, Sector III, Kolkata WEST BENGAL enadle@msn.com abhi-danait@yahoo.co m dribasumd@yahoo.co.i n drmaheshpadsalge2gm ail.com dr.v.mitra@gmail.com of Committee Approval Status Date of Approval Is Committee? Dr. Babasaheb Ambedkar Medical Research Society's Ethics Aurangabad for Dr. Vikas Ratnaparkhe Navi Sangvi, for Dr. Ashish P. Badadare Navi Sangvi, for Dr. Danait Abhijeet Prakash Navi Sangvi, for Dr. Debasis Mitra Navi Sangvi, for Dr. Dr. Sudhir Bhatnagar, MD (MED) page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Navi Sangvi, for Dr. Indraneel Basu Navi Sangvi, for Dr. Mahesh V. Padsalge Navi Sangvi, for Dr. Rajeev C. Naik Navi Sangvi, for Dr. Rajesh P. Enadle Navi Sangvi, for Dr. S. Balamurugan Navi Sangvi, for Dr. Shivram Bhonagiri Navi Sangvi, for Dr. Suresh Gaikwad Status Approved/Obtained Health Type Date No Date Specified Condition Type Details Intervention Fixed Dose Combination of S (-) Amlodipine besylate (2.5 mg / 5 mg) with Clopidogrel bisulphate (75 mg) tablet Comparator Agent NIL NIL Inclusion Criteria Hypertensive patients with ischemic heart disease (IHD) /diabetes mellitus / peripheral vascular disease OR subjects with previous history of cerebrovascular accident OR subjects who are at high risk for atherothrombotic events; requiring antiplatelet therapy orally once daily page 4 / 6

5 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age From Age To Gender Details Details Not Applicable Centralized Open Label Male or female subjects between years of age. Subjects with hypertension Subjects with ischemic heart disease (IHD) / diabetes mellitus / peripheral vascular disease OR subjects with previous history of cerebrovascular accident OR subjects who are at high risk for atherothrombotic events Subject willing to give written informed consent and willing to comply with study protocol Exclusion Criteria Subjects previously sensitive to Amlodipine, S-Amlodipine, Clopidogrel, or to any of the ingredients of the fixed dose combination under study. Subjects with Hypertension, requiring antihypertensive therapy other than Amlodipine. Subjects with history of secondary or Malignant Hypertension. Subjects requiring multidrug antihypertensive therapy. Subjects with cardiac arrhythmia or any abnormality on ECG. Patients with significant respiratory/liver/kidney/neurological/ metabolic or endocrinal disorder (excluding type 2 Diabetes Mellitus) diseases Patients with active pathological bleeding OR history of bleeding tendencies or bleeding disorders. 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. Primary Outcome Outcome Timepoints 1) Control of blood pressure 2) Any Day 0 and after 4, 8 and 12 weeks of therapy. cardiovascular/ atherothrombotic event 3) Global assessment will be done after 12 weeks Subject?s global assessment about the of therapy. Investigations will be done at day 0 tolerability of the drug 4) Physician?s global and after 12 weeks of therapy assessment about the tolerability of the drug 5) Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator 6) CBC (Complete Blood Count), LFT (Liver Function Test), KFT (Kidney Function Test) Lipid profile, FBG (Fasting Blood Glucose), and ECG (Electrocardiogram) Secondary Outcome Outcome Timepoints Target Sample Size None Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Total Sample Size=100 Sample Size from = No Date Specified 01/12/2010 Years= None page 5 / 6

6 Powered by TCPDF ( Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Months=0 Days=0 Completed This multicentric, open label, non-comparative clinical trial is planned to assess efficacy and safety of FDC of S? Amlodipine besylate (2.5/5 mg) and Clopidogrel bisulphate (75 mg) Tablet. Patients stisfing Patient satisfying inclusion and exclusion criteria will receive Fixed Dose Combination of S (-) Amlodipine besylate (2.5 mg / 5 mg) with Clopidogrel bisulphate (75 mg) tablet orally once a day. Dose will modified in subsequent visit to S (-) Amlodipine besylate (2.5 mg) with Clopidogrel bisulphate (75 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. The study duration is of 12 weeks page 6 / 6