Cardiovascular DiseasesNCT00443794
The Indian POLYCAP Study (TIPS)
A study testing Thiazides, Ramipril with Thiazide and Thiazide plus atenolol in people with Cardiovascular Diseases, run by St. John's Research Institute at 54 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Thiazides, Ramipril with Thiazide and Thiazide plus atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,050 participants
- Where
- 54 sitesIndia
- Study dates
- Mar 2007to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
India54 sites
Aditya nursing Home
Adoni, Andhra Pradesh
Gowri Gopal Nursing Home
Adoni, Andhra Pradesh
Care Cardiovascular Consultant
Ahmedabad, Gujarat
V S hospital
Ahmedabad, Gujarat
Bethesda Hospital
Ambur, Tamil Nadu
ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology
Bangalore, Karnataka, 560 034
St John'S Medical College Hospital, Department of Medicine
Bangalore, Karnataka, 560034
Mahaveer Jain Hospital
Bangalore, Karnataka
Workhardt Hospital
Bangalore, Karnataka
Belgaum Diabetes
Belagavi, Karnataka
Apex Research Center and Hospital
Bhopal, Madhya Pradesh
S P Medical College
Bikaner, Rajasthan
Baby Memorial Hospital
Calicut, Kerala
Frontier Lifeline
Chennai, Tamil Nadu
Madras Diabetic Research Foundation
Chennai, Tamil Nadu
Rajamuthaiah Hospital, Annamalianagar
Chennai, Tamil Nadu
Sri Ramachandra Hospital
Chennai, Tamil Nadu
PSG Hospital
Coimbatore, Tamil Nadu
Apollo Hospital
Hyderabad, Andhra Pradesh
Care Hospital, Banjarahills
Hyderabad, Andhra Pradesh
Care Hospital, Nampalli
Hyderabad, Andhra Pradesh
Durga Bai Deshmuk Hospital
Hyderabad, Andhra Pradesh
Global hospital
Hyderabad, Andhra Pradesh
Mahavir Hospital
Hyderabad, Andhra Pradesh
MGM
Indore, Madhya Pradesh
Monilek Hospital
Jaipur, Rajasthan
Tongia Heart Hospital
Jaipur, Rajasthan
Amrita Institute of medical Science
Kochi, Kerala
Peerless Hospital and BK Roy esearch Center
Kolkata, West Bengal
Vijaya Durga Cardiac Centre
Kurnool, Andhra Pradesh
Vijaya Hospital
Kurnool, Andhra Pradesh
King George Hospital
Lucknow, Uttar Pradesh
Sanjay Gandhi PGMI
Lucknow, Uttar Pradesh
Sidhu Hospital
Ludhiana, Punjab
Bhatia Hospital
Mumbai, Maharashtra
C H L Apollo Hospital
Mumbai, Maharashtra
Health Harmony Hospital
Mumbai, Maharashtra
Vikaram Hospital and Health Care
Mysore, Karnataka
Avanti Institute of Cardiology
Nagpur, Maharashtra
Cresent Hospital and Research center
Nagpur, Maharashtra
Sri Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi
Fortis Hospital
Noida, National Capital Territory of Delhi
Sadbhavana Heart Institute
Patiāla, Punjab
Poona Hospital
Pune, Maharashtra
Care Hospital
Secunderabad, Andhra Pradesh
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh
Nanjappa Hospital
Shimoga, Karnataka
West Fort Hospital
Thrissur, Kerala
Ramakrishna Nursing Home
Trichy, Tamil Nadu
Kerala Institute of Medical sciences
Trivandrum, Kerala
Dev Hospital and ICU
Vadodara, Gujarat
Christian Medical College Hospital
Vellore, Tamil Nadu
Care Hospital
Visakhapatnam, Andhra Pradesh
Mahatma Gandhi Institute of Medical Sciences
Wardha, Maharashtra
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Thiazides, Ramipril with Thiazide, Thiazide plus atenolol, Ramipril plus atenolol, Ramipril plus atenolol plus thiazide
- Keywords
- POLYCAP, Primary Prevention,CVD
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiazidesDrug
Capsule (blinded) oral administration once daily for 12 weeks
Ramipril with ThiazideDrug
Capsule (blinded) oral administration 12 weeks
Thiazide plus atenololDrug
Caspule (blinded) for oral administration once daily for 12 weeks
Ramipril plus atenololDrug
Capsule ( blinded) for oral administration once daily for 12 weeks
Ramipril plus atenolol plus thiazideDrug
Capsule (blinded) for oral administration once daily for 12 weeeks
POLYCAPDrug
Also called Quintapill(R)
Capsule for Oral Administration once daily for 12 weeks
Thiazide + Ramipril+Atenolol+AspirinDrug
Capsule (Blinded) for oral administration once daily for 12 weeks
SimvastatinDrug
Capsule (Blinded) for oral administration once daily for 12 weeks
aspirinDrug
capsule (Blinded) for oral administration once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1, POLYCAP | Experimental | Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent Receives: Drug: POLYCAP |
| 2 B | Active comparator | Diuretic antihypertensive Receives: Drug: Thiazides |
| 3 C | Active comparator | Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive. Receives: Drug: Ramipril with Thiazide |
| 4 D | Active comparator | Diuretic with Beta blocker combination antihypertensive Receives: Drug: Thiazide plus atenolol |
| 5, E | Active comparator | ACE inhibitor plus Beta blocker combination antihypertensive Receives: Drug: Ramipril plus atenolol |
| 6, F | Active comparator | Combination antihypertensive of ACE inhibitor, diuretic and beta blocker Receives: Drug: Ramipril plus atenolol plus thiazide |
| 7,G | Active comparator | Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet Receives: Drug: Thiazide + Ramipril+Atenolol+Aspirin |
| 8,H | Active comparator | Lipid lowering agent Receives: Drug: Simvastatin |
| 9,A | Active comparator | Antiplatelet Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in blood Pressure
Measured: 12 weeks
reduction in Heart Rate
Measured: 12 weeks
modify lipids
Measured: 12 weeks
Secondary outcomes (1)
Platelet aggregation
Measured: 12 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cadila Pharnmaceuticals, Population Health Research Institute
- Investigators
- Prem Pais, MD Medicinie, Study chair, Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, IndiaDenis Xavier, MD Pharmac, Study director, HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,Salim Yusuf, DPhil,FRCPC,FRSC, Study chair, Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443794
- Sponsor's protocol ID
- Rx-Medical-CVS-06-01
- Status last verified
- Sep 2010
- First submitted
- 14 Feb 2007
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Indian Polycap Study (TIPS); Yusuf S, Pais P, Afzal R, Xavier D, Teo K, Eikelboom J, Sigamani A, Mohan V, Gupta R, Thomas N. 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.
PubMed 19339045Xavier 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.
PubMed 19104516
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00443794
- Acronym / sponsor ID
- Rx-Medical-CVS-06-01
- Conditions
- Cardiovascular Diseases
- Keywords
- POLYCAP, Primary Prevention,CVD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,050 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- Cadila Pharnmaceuticals, Population Health Research Institute
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1, POLYCAP | Experimental | Drug: POLYCAPCombination of 3 anti hypertensives, lipid lowering agent and anti platelet agent |
| 2 B | Active comparator | Drug: ThiazidesDiuretic antihypertensive |
| 3 C | Active comparator | Drug: Ramipril with ThiazideThiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive. |
| 4 D | Active comparator | Drug: Thiazide plus atenololDiuretic with Beta blocker combination antihypertensive |
| 5, E | Active comparator | Drug: Ramipril plus atenololACE inhibitor plus Beta blocker combination antihypertensive |
| 6, F | Active comparator | Drug: Ramipril plus atenolol plus thiazideCombination antihypertensive of ACE inhibitor, diuretic and beta blocker |
| 7,G | Active comparator | Drug: Thiazide + Ramipril+Atenolol+AspirinCombination of ACE inhibitor, betablocker, diuretic and Antiplatelet |
| 8,H | Active comparator | Drug: SimvastatinLipid lowering agent |
| 9,A | Active comparator | Drug: aspirinAntiplatelet |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 45 and 80 years
- At least any one of the following CVD risk factors:
- Informed consent.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiazidesCapsule (blinded) oral administration once daily for 12 weeks | Drug | 2 B |
| Ramipril with ThiazideCapsule (blinded) oral administration 12 weeks | Drug | 3 C |
| Thiazide plus atenololCaspule (blinded) for oral administration once daily for 12 weeks | Drug | 4 D |
| Ramipril plus atenololCapsule ( blinded) for oral administration once daily for 12 weeks | Drug | 5, E |
| Ramipril plus atenolol plus thiazideCapsule (blinded) for oral administration once daily for 12 weeeks | Drug | 6, F |
| POLYCAPAlso: Quintapill(R)Capsule for Oral Administration once daily for 12 weeks | Drug | 1, POLYCAP |
| Thiazide + Ramipril+Atenolol+AspirinCapsule (Blinded) for oral administration once daily for 12 weeks | Drug | 7,G |
| SimvastatinCapsule (Blinded) for oral administration once daily for 12 weeks | Drug | 8,H |
| aspirincapsule (Blinded) for oral administration once daily for 12 weeks | Drug | 9,A |
Primary outcome
Reduction in blood Pressure
Time frame: 12 weeks
reduction in Heart Rate
Time frame: 12 weeks
modify lipids
Time frame: 12 weeks
1 secondary outcome
Platelet aggregation
Time frame: 12 weks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2010.
- Background: PubMed 19339045Indian Polycap Study (TIPS); Yusuf S, Pais P, Afzal R, Xavier D, Teo K, Eikelboom J, Sigamani A, Mohan V, Gupta R, Thomas N. 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.
- Derived from this study: PubMed 19104516Xavier 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.
- Division of Clinical Trials , St John's Research Institute, WebsiteLink provided by the sponsor.
- Cadila PharmaceuticalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prem Pais, MD Medicinie study chair
Dean, Professor of Medicine, St Johns Medical College, Head Division of Clinical Trials St John's Research Institute, Bangalore, India
Denis Xavier, MD Pharmac study director
HOPE Research Scholar, Department of Medicine, PHRI, McMaster University, Hamilton, ON, Canada,
Salim Yusuf, DPhil,FRCPC,FRSC study chair
Director, Population Health Research Institute, Mc Master University, Hamilton, ON, CANADA
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiazides, Ramipril with Thiazide and Thiazide plus atenolol in people with Cardiovascular Diseases, run by St. John's Research Institute at 54 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in blood Pressure (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00443794, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2010; AzTrials last refreshed its copy on 28 Oct 2026.