The Indian POLYCAP Study (TIPS)
- Conditions
- Cardiovascular Diseases
- Interventions
- Drug: ThiazidesDrug: Thiazide + Ramipril+Atenolol+Aspirin
- Registration Number
- NCT00443794
- Lead Sponsor
- St. John's Research Institute
- Brief Summary
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.
STUDY 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.
STUDY DESIGN
Randomized controlled double-blind trial of the POLYCAP® versus its components in eight formulations.
STUDY POPULATION Subjects between 45 and 80 years of age, with at least one additional CVD risk factor.
INVESTIGATIONAL 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.
There 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.
OUTCOME MEASURES Mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.
STATISTICAL 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2050
-
Age between 45 and 80 years
-
At least any one of the following CVD risk factors:
- Stable type 2 diabetes mellitus or
- Hypertension or
- Current smoker or
- A waist to hip ratio > 0.85 for women and >0.9 for men or
- Elevated lipids.
-
Informed consent.
- On any of the study medications,
- Uncontrolled blood pressure,
- Symptomatic hypotension,
- Any clear indication or a contraindication to the use of any of the study medications,
- History of coronary/cerebrovascular events,
- Pregnancy or lactating or women of child-bearing potential with inadequate contraception and / or an inability to attend follow up visits.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6, F Ramipril plus atenolol plus thiazide Combination antihypertensive of ACE inhibitor, diuretic and beta blocker 2 B Thiazides Diuretic antihypertensive 1, POLYCAP POLYCAP Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent 3 C Ramipril with Thiazide Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive. 4 D Thiazide plus atenolol Diuretic with Beta blocker combination antihypertensive 5, E Ramipril plus atenolol ACE inhibitor plus Beta blocker combination antihypertensive 7,G Thiazide + Ramipril+Atenolol+Aspirin Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet 8,H Simvastatin Lipid lowering agent 9,A aspirin Antiplatelet
- Primary Outcome Measures
Name Time Method Reduction in blood Pressure 12 weeks reduction in Heart Rate 12 weeks modify lipids 12 weeks
- Secondary Outcome Measures
Name Time Method Platelet aggregation 12 weks
Trial Locations
- Locations (53)
MGM
🇮🇳Indore, Madhya Pradesh, India
Sri Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Fortis Hospital
🇮🇳Noida, Delhi, India
S P Medical College
🇮🇳Bikaner, Rajasthan, India
Christian Medical College Hospital
🇮🇳Vellore, Tamil Nadu, India
Tongia Heart Hospital
🇮🇳Jaipur, Rajasthan, India
Monilek Hospital
🇮🇳Jaipur, Rajasthan, India
Health Harmony Hospital
🇮🇳Mumbai, Maharastra, India
Madras Diabetic Research Foundation
🇮🇳Chennai, Tamilnadu, India
Peerless Hospital and BK Roy esearch Center
🇮🇳Kolkata, West Bengal, India
Bethesda Hospital
🇮🇳Ambur, Tamilnadu, India
Sadbhavana Heart Institute
🇮🇳Patiala, Punjab, India
Mahatma Gandhi Institute of Medical Sciences
🇮🇳Wardha, Maharastra, India
Care Hospital, Banjarahills
🇮🇳Hyderabad, Andhra Pradesh, India
Aditya nursing Home
🇮🇳Adoni, Andhra pradesh, India
Vijaya Durga Cardiac Centre
🇮🇳Kurnool, Andhra Pradesh, India
V S hospital
🇮🇳Ahmedabad, Gujrat, India
Dev Hospital and ICU
🇮🇳Baroda, Gujrat, India
Care Cardiovascular Consultant
🇮🇳Ahmedabad, Gujrat, India
Care Hospital
🇮🇳Vishakapatnam, Andhra Pradesh, India
Vijaya Hospital
🇮🇳Kurnool, Andhra Pradesh, India
Workhardt Hospital
🇮🇳Bangalore, Karnataka, India
St John'S Medical College Hospital, Department of Medicine
🇮🇳Bangalore, Karnataka, India
Mahaveer Jain Hospital
🇮🇳Bangalore, Karnataka, India
Vikaram Hospital and Health Care
🇮🇳Mysore, Karnataka, India
Baby Memorial Hospital
🇮🇳Calicut, Kerala, India
Nanjappa Hospital
🇮🇳Shimoga, Karnataka, India
Amrita Institute of medical Science
🇮🇳Cochin, Kerala, India
Kerala Institute of Medical sciences
🇮🇳Trivandrum, Kerala, India
C H L Apollo Hospital
🇮🇳Mumbai, Maharastra, India
Sidhu Hospital
🇮🇳Ludhiana, Punjab, India
Care Hospital, Nampalli
🇮🇳Hyderabad, Andhra pradesh, India
Durga Bai Deshmuk Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Mahavir Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Krishna Institute of Medical Sciences
🇮🇳Secunderabad, Andhra Pradesh, India
Poona Hospital
🇮🇳Pune, Maharastra, India
Ramakrishna Nursing Home
🇮🇳Trichy, Tamilnadu, India
Rajamuthaiah Hospital, Annamalianagar
🇮🇳Chennai, Tamilnadu, India
West Fort Hospital
🇮🇳Thrissur, Kerala, India
Gowri Gopal Nursing Home
🇮🇳Adoni, Andhra Pradesh, India
Apex Research Center and Hospital
🇮🇳Bhopal, Madhya Pradesh, India
Apollo Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Avanti Institute of Cardiology
🇮🇳Nagpur, Maharastra, India
PSG Hospital
🇮🇳Coimbatore, Tamilnadu, India
Sri Ramachandra Hospital
🇮🇳Chennai, Tamilnadu, India
Frontier Lifeline
🇮🇳Chennai, Tamilnadu, India
ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology
🇮🇳Bangalore, Karnataka, India
Global hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Bhatia Hospital
🇮🇳Mumbai, Maharastra, India
Cresent Hospital and Research center
🇮🇳Nagpur, Maharastra, India
Belgaum Diabetes
🇮🇳Belgaum, Karnataka, India
Sanjay Gandhi PGMI
🇮🇳Lucknow, Uttar Pradesh, India
King George Hospital
🇮🇳Lucknow, Uttar Pradesh, India