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Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 10:05:43 GMT)
CTRI Number CTRI/2011/06/001821 [Registered on: 21/06/2011] - Trial Registered Prospectively Last Modified On 31/12/2015 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People (APOLLO) Scientific Title of A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Study Elderly People Secondary IDs if Any Secondary ID Identifier CSPP100G2301 Protocol Number NCT01259297 ClinicalTrials.gov Details of Principal Details of Principal Investigator Investigator or overall Name Trial Coordinator (multi-center study) Designation Affiliation Address
Phone Fax Email Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Murugananthan K Query) Designation Head-Clinical Development Affiliation Novartis Heathcare Pvt Ltd Address Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai Mumbai MAHARASHTRA 400 018 India Phone 02224958545 Fax 02224954112 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Murugananthan K Designation Head-Clinical Development Affiliation Novartis Heathcare Pvt Ltd Address Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai Mumbai MAHARASHTRA 400 018 India Phone 02224958545
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Fax 02224954112 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Novartis Pharma AG, Basel, Switzerland Primary Sponsor Primary Sponsor Details Name Novartis Healthcare Pvt Ltd Address Medical Dept, Sandoz House, Shiv Sagar Estate, dr A. B. road, Worli Mumbai Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor NIL Countries of List of Countries Recruitment Argentina Brazil Canada Chile Colombia Czech Republic Germany Hungary India Ireland Malaysia Netherlands Philippines Russian Federation South Africa Spain Sweden Turkey Ukraine United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DrSudhir Bhatnagar Abhinav Multispeciality Medicine,Kamal Chowk 2641710 Hospital ,Nagpur,MAHARASHT 7122631706 RA-440 017,INDIA drsudhirbhatnagar@gm Nagpur ail.com MAHARASHTRA Dr B Srinivasulu Aditya Nursing Home, PHYSICIAN,1-541-135 9849393369 Adoni AA&S COLLEGE 8512231392 ROAD ADONI adityanursinghome@ya ANDHRA hoo.com PRADESH-518302 INDIA Kurnool ANDHRA PRADESH Dr VL Gupta Avanti Institute of NEPHROLOGY,5. 7122440335 Cardiology Pvt. Ltd., ABHYANKAR ROAD, 7122461599 Nagpur DHANTOLI NAGPUR [email protected]
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MAHARASTRA-440012 INDIA Nagpur MAHARASHTRA DrNeeta RDeshpande Belgaum Diabetes DIABETOLOGY,MARU 91988027131 Centre, Belgaum TI GAUZ,BELGAUM,K 918314215380 ARNATAKA-590001 [email protected] Belgaum KARNATAKA DrK Joel Nesaraj Bethesda Hospital, PHYSICIAN,Ambur-635 04174-245231 Ambur 802, Vellore 04174-245231 DistrictAmburTamil [email protected] Nadu-635802 om Vellore TAMIL NADU Dr Sunil V Sathe Cardiac Care & CARDIOLOGY,775/1, 2025663890 Counseling Center KETKAR PATH, PARK 2066439130 PLAZA, OPP KAMLA [email protected] NEHRU PARK PUNE MAHARASHTRA-4110 04 INDIA Pune MAHARASHTRA DrMalipeddi Bhaskar Care Hospital CARDIOLOGY10-50-11 91891-6617791 Rao /5, waltair main road,Ra 91891-6617791 mnagar,Visakhapatnam bhaskarstudies@hotma ,Andhra il.com Pradesh-530002,India. Visakhapatnam ANDHRA PRADESH Dr Keyur Parikh Care Institute of Medi CARDIOLOGY,OFF 917927712771 cal Sciences SCIENCE CITY ROAD, 917927712777 SOLA AHMEDABAD keyur.parikh@heartcare GUJARAT-380060 clinic.org INDIA Ahmadabad GUJARAT Dr Pothineni Ramesh Dr Ramesh Cardiac & CARDIOLOGY,Dr. 9848499588 Babu Multispeciality Hosp. Ramesh Cardiac and 918662473554 Ltd Multispeciality Hospital dr_rameshbabu_p@ya Ltd. Ring Road, hoo.co.in Vijayawada Andhra Pradesh- 520008 INDIA Krishna ANDHRA PRADESH Dr Kamal Sharma Dr. Kamal Sharmas A-406,4thfloor, Shivalik 9426020154 Cardiology Clinic, Yash, Ankur cross Ahmedabad Road, 132 ft ring kamalsharma1975@red road,Naranpura, iffmail.com AHMEDABAD GUJARAT-380013 Ahmadabad GUJARAT DrKetan K Mehta Health Harmony DEPT OF 02228827500 MEDICINE,2-Dattani 02228890821 Chambers, SV Road, M [email protected] alad-W,Mumbai-400064 m ,MAHARASTRA,India Mumbai
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MAHARASHTRA Dr Rajesh Bhat U Justice K.S. Hegde CARDIOLOGY,Deralak 9448248780 Charitable Hospital atte, MANGALORE KARNATAKA-575018 [email protected] INDIA Dakshina Kannada KARNATAKA Dr P Rajendra Kumar Krishna Institute of CARDIOLOGY,1-8-31/1 4044885363 Premchand Medical Sciences Ltd., MINISTER ROAD, 4040045215 Secunderabad SECUNDERABAD, [email protected] ANDHRA PRADESH-5 00003,INDIA Hyderabad ANDHRA PRADESH DrSandeep Kumar M.V.Hospital & CARDIOLOGY,314/30 5222258215 Gupta Research Centre, MIRZA MANDI, 6224016051 Lucknow CHOWK, LUCKNOW, sandeepkumar.gupta@ UTTAR rediffmail.com PRADESH-226003, INDIA Lucknow UTTAR PRADESH DrV Mohan Madras Diabetes CLINICAL TRIAL,NO: 914443446204 Centre, Chennai 4, CONRAN SMITH 914443446208 ROAD, [email protected] GOPALAPURAM CHENNAI TAMILNADU-6000086 INDIA Chennai TAMIL NADU DrSP Kalantri Mahatma Gandhi DEPARTMENT OF 07152284967 Institute of Medical MEDICINE WARDHA Sciences, Sevagram MAHARASHTRA-4421 [email protected] 02INDIA Wardha MAHARASHTRA DrSindhu Joshi Mahavir Hospital & PHYSICIAN,10-1-1 4023497699 Research Centre, A.C. GUARDS 4023320447 Hyderabad MASABTANK, [email protected] Hyderabad,ANDHRA PRADESH-500004 INDIA Hyderabad ANDHRA PRADESH Dr Naveen Reddy Mediciti Hospitals CARDIOLOGY,5-9-22 91402323111 SECRETARIAT ROAD 914023299078 HYDERABAD prodduturnaveen@yah AP-500063 INDIA oo.co.in Hyderabad ANDHRA PRADESH DrJNarendra Nanjappa Hospital CARDIOLOGY,No. 918182225085 5619, Gadikoppa, 8182225085 Sagar Road,Shimoga,K [email protected] arnataka-577205,India m Shimoga KARNATAKA DrPramod Mundra Platina Heart Hospital CARDIOLOGY,Dhanas 9823026651 hree Commercial
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Complex, Sitabuldi,Nag pramod_mundra@rediff pur,MAHARASHTRA-4 mail.com 40 012,INDIA Nagpur MAHARASHTRA DrVK Katyal Post Graduation DEPT OF 1262211300 Institute of Medical MEDICINE,20/8 FM, Sciences, Rohtak MEDICAL ENCLAVE katyalvirander@hotmail ROHTAK .com HARYANA-124001 INDIA Rohtak HARYANA Dr Abraham Oomman Ramana Maharshi CARDIOLOGY,ATHIYA 4175236108 Rangammal Hospital NDAL 4175236108 TIRUVANNAMALAI drabrahamoomman@g TAMIL mail.com NADU-606603INDIA Tiruvanamalai TAMIL NADU DrR BPanwar S. P. Medical College, DEPT OF 911512525451 Bikaner CARDIOLOGY,Bikaner, 911512205327 Rajasthan-334001,India research_spmc@yahoo . .com Bikaner RAJASTHAN DrNakul Sinha Sahara Hospital CARDIOLOGY,GomtiN 5226782026 agar,Lucknow,U.P.-226 915226782110 010,India [email protected] Lucknow UTTAR PRADESH DrShantanu Sengupta Sengupta Hospital & PHYSICIAN,Ravinagar 2536628 Research Institute Square,Nagpur,MAHAR 917122565597 ASHTRA-440 [email protected] 033,INDIA Nagpur MAHARASHTRA Dr Gursaran Sidhu Sidhu Hospital, Doraha DEPARTMENT OF 1628257014 MEDICINE,G.T. ROAD, 1628501341 DORAHA DISTT. [email protected] LUDHIANA om PUNJAB-141421 INDIA Ludhiana PUNJAB Dr J A Tharakan Sree Chitra Tirunal CARDIOLOGY,Medical 0471-2524455 Institute for Medical College P.OTrivandrum 0471-2550728 Sciences ,Kerala-695011,India jaganmohan.tharakan@ Thiruvananthapuram gmail.com KERALA Dr Balaji Y Sri Balaji Medical & PHYSICIAN,GIRLS 8512253785 Diabetic Care Centre, HIGH SCHOOL ROAD, 8512253785 Adoni NEAR II TOWN [email protected] POLICE STATION, Adoni - 518301 Kurnool ANDHRA PRADESH DrCBPatil St. Johns Medical ENDOCRINOLOGY,De 8025633087 College Hospital, partment of Cardiology, 8025630603 Bangalore 3rd Floor Sarjapur cardioresearch@gmail.
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Road,Koramangala com Bangalore, KARNATAKA-560034 Bangalore KARNATAKA Dr Nitish Garg Tagore Heart Care And R&D DEP,BANDA 911814685777 Research Centre BAHADUR NAGAR, 911812204408 MAHAVIR MARG [email protected] JALANDHAR m PUNJAB-144008 INDIA Jalandhar PUNJAB Dr Tejas Patel TCVS Pvt. Ltd CARDIOLOGY,KEDAR 917926466161 1ST AND 4TH FLOOR, 917926407711 NR, PARIMAL [email protected] CROSSROADS rg AHMEDABAD GUJARAT-380006 INDIA Ahmadabad GUJARAT Dr Balraj Bosco Trichy Diabetes B-37 SASTHRI ROAD, 4312742091 Speciality Centre (P) VII CROSS EAST 4314021782 Ltd., Trichy THILLAINAGAR, Trichy [email protected] 620018 Tiruchirappalli TAMIL NADU Dr Sunil Dwivedi Vikram Hospital CARDIOLOGY, 71/1 9845132745 MILLERS ROAD, BANGALORE 52 dwivediksunil@rediffma BANGALORE il.com KARNATAKA-560052 INDIA Bangalore KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Central Ethics Submittted/Under No Date Specified No committee, Justice K.S. Review Hegde Charitable Hospital City Cardiac Submittted/Under No Date Specified No Institutional Ethics Review Committee,Dr. Ramesh Cardiac & Multispeciality hospital Ethics Committee of Submittted/Under No Date Specified No Biniwale Clinic,Cardiac Review Care & Counseling Center Ethics Committee, Care Submittted/Under No Date Specified No Institute of Medical Review Sciences Ethics Committee, Submittted/Under No Date Specified No Sahara Review Hospitals,Lucknow Ethics Submittted/Under No Date Specified No Committee,Mahavir Review
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Hospital & Research Centre, Hyderabad Ethics Submittted/Under No Date Specified No Committee,Ramana Review Maharshi Rangammal Hospital,Tamil Nadu, Ethics Submittted/Under No Date Specified No Committee-Avanti Review Institute of Cardiology Pvt Ltd, Nagpur Ethics Committee. Approved 14/04/2011 No Independent Ethics Approved 13/07/2011 Yes Committee Consultant,Dr. Neeta Despande, BELGAUM Independent Ethics Approved 21/07/2011 Yes Committee Consultant. Independent Ethics Approved 22/06/2011 Yes Committee Consultants, Bangalore. Independent Ethics Submittted/Under No Date Specified Yes Committee Review Consultants,Dr.Ketan K.Mehta, Mumbai. Independent Ethics Approved 29/06/2011 Yes Committee Consultants,Vikram Hospital Independent Ethics Approved 29/06/2011 Yes Committee Consultants, Y.Balaji,ANDHRA PRADESH Independent Ethics Approved 13/07/2011 Yes CommitteeConsultant, Bethesda Hospital, Ambur Indepent Ethics Approved 13/07/2011 Yes Comittee Consultants Indepent Ethics Approved 06/07/2011 Yes Committee Consultants, Dr. Balraj Bosco,TAMIL NADU. Institute Ethics Submittted/Under No Date Specified No Committee,Krishna Review Institute of Medical Sciences Ltd.,Dr. Rajendra Kumar P, SECUNDERABAD Institutional Ethical Submittted/Under No Date Specified No Review Review board,Dr.Ganapathi Bantwal,Bangalore Institutional Ethics Submittted/Under No Date Specified No Committee Madras Review Diabetes Research Foundation,CHENNAI Institutional Ethics Approved 01/10/2011 No
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Committee, SCTIMST,Trivandrum Institutional Ethics Submittted/Under No Date Specified No committee,Care Review Hospital,Malipeddi Bhaskar Rao Institutional Ethics com Submittted/Under No Date Specified No mittee,Dr.M.V.Hospital Review and Research Centre,LUCKNOW Institutional Ethics Submittted/Under No Date Specified No Committee,Mahatma Review Gandhi Institute of Medical Sciences, Sevagram lInstitutional Ethics Submittted/Under No Date Specified No committee, Review PT.B.D.Sharma Post graduate Institute of Medical Sciences,ROHTAK Mediciti Ethics Approved 11/04/2011 No Committee,Mediciti Hospitals,HYDERABAD Nagpur Independent Submittted/Under No Date Specified Yes Ethics Committee Review Nagpur Independent Submittted/Under No Date Specified Yes Ethics Committee. Review Nagpur Independent Submittted/Under No Date Specified Yes Ethics-Committee. Review Sujlam Independent Submittted/Under No Date Specified Yes Ethics Review Committee,Dr.Tejas Patel,AHMEDABAD Tagore Hospital & Approved 16/05/2011 Yes Heart Care Centre Ethics committee,Tagore Heart Care And Research Centre,Dr.Nitish Garg. Tagore Hospital & Submittted/Under No Date Specified Yes Heart Care Centre Review Ethics Committee. Regulatory Clearance Status Date Status from DCGI Approved/Obtained 19/05/2011 Health Condition / Health Type Condition Problems Studied Patients Cardiovascular Events Intervention / Type Name Details Comparator Agent Intervention Aliskiren Orally active nonpeptidic renin inhibitor. Each patient will take study medication by mouth (p.o.) with water per day throughout the run-in and the randomized phases. Study medication should be taken in
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the mornings each day. The average duration of therapy is about 5 years. Intervention Amlodipine/HCTZ A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of angina pectoris and hypertension/Diuretic HCTZ 12.5 mg daily The average duration of therapy is about 5 years. the Average duration of therapy is 5 years. Comparator Agent Placebo Matching to intervention Duration of therapy is 5 years. Inclusion Criteria Inclusion Criteria Age From 65.00 Year(s) Age To 90.00 Year(s) Gender Both Details Systolic blood pressure 130 - 159 mmHg with any one of the following (1, 2 or 3):
1. Men and women aged greater than equal to 65 years if they have at least one of the following: (secondary prevention) Coronary heart disease
o Previous myocardial infarction or
o Stable angina or unstable angina with documented multi-vessel coronary artery disease, l 50 percentage stenosis in at least 2 major coronary arteries on coronary angiography, or positive stress test (ECG or nuclear perfusion scintogram), or
o Multi-vessel PCI, or
o Multi-vessel CABG surgery greater than4 years prior to informed consent, or with recurrent angina or ischemia following surgery Stroke/TIA Previous documented stroke or documented TIA less than 1 year before informed consent Peripheral artery disease
o Previous limb bypass surgery or percutaneous transluminal angioplasty, or
o Previous limb or foot amputation, or
o History of intermittent claudication, with an ankle:arm BP ratio less than equal to 0.80 on at least one side, or significant peripheral artery stenosis (greater than 50 percentage) documented by angiography or non-invasive testing Diabetes mellitus High-risk diabetics with evidence of end-organ damage
2. Men and women aged greater than equal to 65 years with no history of CVD, and with at least 1 CV risk factor (primary prevention):
o History of dyslipidemia, defined as LDL cholesterol greater than 3.5 mmol per L (135 mg per dL) or HDL less than1.3 mmol per L (50 mg per dL) in women or less than 1.0 mmol per L (39 mg per dL) in men or total cholesterol per HDL ratio greater than 5
o History of current or recent smoking (regular tobacco use within 5 years)
o Abdominal adiposity defined as waist per hip ratio greater than equal to 0.90 in women and greater than equal to 0.95 in men
o History of dysglycemia defined as impaired fasting glucose (IFG - fasting plasma glucose 5.6 to 6.9 mmol per L [101 to 124 mg per dL]), or impaired glucose tolerance (IGT - fasting plasma glucose less than7 mmol per L [126 mg per dL] but 2 hour glucose 7.8 to 11.0 mmol per L [140 to 198 mg per dL]) or type 2 diabetes
o Renal dysfunction: eGFR less than 60 ml per min per 1.73m2 but greater than 30 ml per min per 1.73m2 (MDRD formula) and/or micro albuminurea per macro albuminurea
o Clinical evidence of left ventricular hypertrophy
3. Men and women aged greater than equal to 70 years if they do not have any of the above (primary prevention)
Exclusion Criteria Exclusion Criteria
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Details 1. Current treatment with aliskiren, an ACE-inhibitor, an ARB or an aldosterone antagonist and unable to discontinue this therapy in those without clinical vascular disease. Individuals with CVD or type 2 diabetes and per or renal dysfunction may receive an ACE-inhibitor or an ARB, but not both, contraindications to aliskiren, amlodipine or hydrochlorothiazide. 2. Use of both thiazide diuretic and amlodipine or another calcium channel blocker Patients on only one of these two classes of drugs are eligible 3. Uncontrolled hypertension (systolic blood pressure greater than equal to160 mmHg and/or diastolic blood pressure greater than equal to 100 mmHg) 4. Symptomatic heart failure, requiring the use of loop diuretics 5. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). Constrictive pericarditis. Complex congenital heart disease. 6. Acute stroke less than 3 months or TIA less than equal to 7 days before informed consent, acute coronary syndrome less than 1 months before informed consent 7. Planned cardiac surgery or angioplasty less than 3 months after informed consent or having had the procedure less than 3 months before informed consent 8. Severe renal impairment eGFR less than equal to 30 ml per minper 1.73m2 (MDRD formula); known renal artery stenosis ; serum potassium greater than equal to 5.3 mmol per L 9. Chronic liver disease (i.e. cirrhosis, esophageal varices, portocaval shunt or persistent hepatitis) or abnormal liver function, i.e., alanine transaminase (ALT) or AST greater than 3x upper limit of normal (ULN) 10. Concurrent treatment with cyclosporine or quinidine; chronic use of non-steroidal anti-inflammatory drug (NSAIDs) or cyclooxygenase-2 (COX 2) inhibitors in patients with eGFR less than 60 ml per min per 1.73m2 (MDRD formula) 11. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years regardless of whether there is evidence of local recurrence or metastases 12. Other serious condition(s) likely to interfere with study participation or with the ability to complete the study. Significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the study procedures
Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints Reduction in risk of major cardiovascular events Time Frame: 6 years (composite of CV death, non-fatal MI, non-fatal stroke and significant heart failure) Time Frame: 6 years Secondary Outcome Outcome Timepoints Prevention of decline in the ability to perform 6 years everyday activities independently Prevention of decline in renal function 6 years
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Reduction of total mortality 6 years Target Sample Size Total Sample Size=11000 Sample Size from India=700 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3 Date of First 16/08/2011 Enrollment (India) Date of First 15/12/2010 Enrollment (Global) Estimated Duration of Years=6 Trial Months=5 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Brief Summary Purpose : This study will provide new information regarding the role of aliskiren in elderly individuals (greater than or equal to 65 years) with SBP 130 to 159 mmHg, in preventing major CV events and on global measures of physical, executive and cognitive function.
FPFV for India:30-June-2011
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