Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT00443794
Status:
COMPLETED
Last Update Posted:
2010-09-23
First Post:
2007-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Indian POLYCAP Study (TIPS)
Sponsor:
Organization:
Raw JSON
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Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial. Lancet. 2009 Apr 18;373(9672):1341-51. doi: 10.1016/S0140-6736(09)60611-5. Epub 2009 Mar 30.'}, {'pmid': '19104516', 'type': 'DERIVED', 'citation': 'Xavier D, Pais P, Sigamani A, Pogue J, Afzal R, Yusuf S; Indian Polycap Study (TIPS) Investigators. The need to test the theories behind the Polypill: rationale behind the Indian Polycap Study. Nat Clin Pract Cardiovasc Med. 2009 Feb;6(2):96-7. doi: 10.1038/ncpcardio1438. Epub 2008 Dec 23. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.sjri.res.in', 'label': "Division of Clinical Trials , St John's Research Institute, Website"}, {'url': 'http://www.cadilapharma.com', 'label': 'Cadila Pharmaceuticals'}]}, 'descriptionModule': {'briefSummary': 'STUDY TITLE A randomized double-blind controlled trial of the efficacy and safety of the POLYCAP® versus its components in subjects aged 45 to 80 years of age with at least one additional cardiovascular risk factor.\n\nSTUDY OBJECTIVES This study is designed to assess the efficacy and safety of the POLYCAP®, a fixed dose combinationcontaining 5 drugs (an antiplatelet drug; 3 blood pressure lowering agents, a beta blocker, an ACE inhibitor, a diuretic and a statin.\n\nSTUDY DESIGN\n\nRandomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.\n\nSTUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.\n\nINVESTIGATIONAL PRODUCTS Composition POLYCAP® and its comparators FOLLOW UP The total duration of follow up will be 4 months, from the start of study medication.. Subjects will take study medication for 3 months. There will be a final follow up visit 1 month after stopping the study medication.\n\nThere will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits for 4 months. Subjects taking any of the study medications prior to enrolment will have one or more additional visits during a defined wash out and before enrolment.\n\nOUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.\n\nSTATISTICAL ISSUES Non-inferiority evaluation of the POLYCAP in modifying BP, lipids and platelet activity \\[as measured by urinary thromboxane\\] when compared with its different components in eight different formulations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 45 and 80 years\n* At least any one of the following CVD risk factors:\n\n * Stable type 2 diabetes mellitus or\n * Hypertension or\n * Current smoker or\n * A waist to hip ratio \\> 0.85 for women and \\>0.9 for men or\n * Elevated lipids.\n* Informed consent.\n\nExclusion Criteria:\n\n* On any of the study medications,\n* Uncontrolled blood pressure,\n* Symptomatic hypotension,\n* Any clear indication or a contraindication to the use of any of the study medications,\n* History of coronary/cerebrovascular events,\n* Pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.'}, 'identificationModule': {'nctId': 'NCT00443794', 'briefTitle': 'The Indian POLYCAP Study (TIPS)', 'organization': {'class': 'OTHER', 'fullName': "St. John's Research Institute"}, 'officialTitle': 'A Randomized Double Blind Controlled Trial of the Efficacy and Safety of POLYCAP (Quintapill)Versus Its Components in Subjects With at Least One Additional Cardiovascular Risk Factor', 'orgStudyIdInfo': {'id': 'Rx-Medical-CVS-06-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1, POLYCAP', 'description': 'Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent', 'interventionNames': ['Drug: POLYCAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 B', 'description': 'Diuretic antihypertensive', 'interventionNames': ['Drug: Thiazides']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 C', 'description': 'Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.', 'interventionNames': ['Drug: Ramipril with Thiazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 D', 'description': 'Diuretic with Beta blocker combination antihypertensive', 'interventionNames': ['Drug: Thiazide plus atenolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5, E', 'description': 'ACE inhibitor plus Beta blocker combination antihypertensive', 'interventionNames': ['Drug: Ramipril plus atenolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6, F', 'description': 'Combination antihypertensive of ACE inhibitor, diuretic and beta blocker', 'interventionNames': ['Drug: Ramipril plus atenolol plus thiazide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '7,G', 'description': 'Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet', 'interventionNames': ['Drug: Thiazide + Ramipril+Atenolol+Aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '8,H', 'description': 'Lipid lowering agent', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '9,A', 'description': 'Antiplatelet', 'interventionNames': ['Drug: aspirin']}], 'interventions': [{'name': 'Thiazides', 'type': 'DRUG', 'description': 'Capsule (blinded) oral administration once daily for 12 weeks', 'armGroupLabels': ['2 B']}, {'name': 'Ramipril with Thiazide', 'type': 'DRUG', 'description': 'Capsule (blinded) oral administration 12 weeks', 'armGroupLabels': ['3 C']}, {'name': 'Thiazide plus atenolol', 'type': 'DRUG', 'description': 'Caspule (blinded) for oral administration once daily for 12 weeks', 'armGroupLabels': ['4 D']}, {'name': 'Ramipril plus atenolol', 'type': 'DRUG', 'description': 'Capsule ( blinded) for oral administration once daily for 12 weeks', 'armGroupLabels': ['5, E']}, {'name': 'Ramipril plus atenolol plus thiazide', 'type': 'DRUG', 'description': 'Capsule (blinded) for oral administration once daily for 12 weeeks', 'armGroupLabels': ['6, F']}, {'name': 'POLYCAP', 'type': 'DRUG', 'otherNames': ['Quintapill(R)'], 'description': 'Capsule for Oral Administration once daily for 12 weeks', 'armGroupLabels': ['1, POLYCAP']}, {'name': 'Thiazide + Ramipril+Atenolol+Aspirin', 'type': 'DRUG', 'description': 'Capsule (Blinded) for oral administration once daily for 12 weeks', 'armGroupLabels': ['7,G']}, {'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Capsule (Blinded) for oral administration once daily for 12 weeks', 'armGroupLabels': ['8,H']}, {'name': 'aspirin', 'type': 'DRUG', 'description': 'capsule (Blinded) for oral administration once daily for 12 weeks', 'armGroupLabels': ['9,A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adoni', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Aditya nursing Home', 'geoPoint': {'lat': 15.62788, 'lon': 77.27495}}, {'city': 'Adoni', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Gowri Gopal Nursing Home', 'geoPoint': {'lat': 15.62788, 'lon': 77.27495}}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Apollo Hospital'}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Care Hospital, Banjarahills'}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Care Hospital, Nampalli'}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Durga Bai Deshmuk Hospital'}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Global hospital'}, {'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Mahavir Hospital'}, {'city': 'Kurnool', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Vijaya Durga Cardiac 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'country': 'India', 'facility': 'PSG Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'city': 'Trichy', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Ramakrishna Nursing Home', 'geoPoint': {'lat': 10.80289, 'lon': 78.69875}}, {'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Christian Medical College Hospital', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Sanjay Gandhi PGMI', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Peerless Hospital and BK Roy esearch Center', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Prem Pais, MD Medicinie', 'role': 'STUDY_CHAIR', 'affiliation': "Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India"}, {'name': 'Denis Xavier, MD Pharmac', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,'}, {'name': 'Salim Yusuf, DPhil,FRCPC,FRSC', 'role': 'STUDY_CHAIR', 'affiliation': 'Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. John's Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cadila Pharnmaceuticals', 'class': 'INDUSTRY'}, {'name': 'Population Health Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Project Director, The Indian Polycap Study Steering Comittee.', 'oldOrganization': "Division of Clinical Trials, St. John's Research Institute"}}}}