The Indian POLYCAP Study (TIPS)

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443794
• Other study ID #: Rx-Medical-CVS-06-01
• Status: Completed
• Phase: N/A
• First received: February 14, 2007
• Last updated: September 22, 2010
• Start date: March 2007
• Est. completion date: October 2008

Study information

• Verified date: September 2010
• Source: St. John's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2050
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Thiazides
Capsule (blinded) oral administration once daily for 12 weeks
• Ramipril with Thiazide
Capsule (blinded) oral administration 12 weeks
• Thiazide plus atenolol
Caspule (blinded) for oral administration once daily for 12 weeks
• Ramipril plus atenolol
Capsule ( blinded) for oral administration once daily for 12 weeks
• Ramipril plus atenolol plus thiazide
Capsule (blinded) for oral administration once daily for 12 weeeks
• POLYCAP
Capsule for Oral Administration once daily for 12 weeks
• Thiazide + Ramipril+Atenolol+Aspirin
Capsule (Blinded) for oral administration once daily for 12 weeks
• Simvastatin
Capsule (Blinded) for oral administration once daily for 12 weeks
• aspirin
capsule (Blinded) for oral administration once daily for 12 weeks

Locations

Country	Name	City	State
India	Aditya nursing Home	Adoni	Andhra pradesh
India	Gowri Gopal Nursing Home	Adoni	Andhra Pradesh
India	Care Cardiovascular Consultant	Ahmedabad	Gujrat
India	V S hospital	Ahmedabad	Gujrat
India	Bethesda Hospital	Ambur	Tamilnadu
India	Mahaveer Jain Hospital	Bangalore	Karnataka
India	St John'S Medical College Hospital, Department of Medicine	Bangalore	Karnataka
India	ST JOHN'S MEDICAL COLLEGE HOSPITAL, Dept of Cardiology	Bangalore	Karnataka
India	Workhardt Hospital	Bangalore	Karnataka
India	Dev Hospital and ICU	Baroda	Gujrat
India	Belgaum Diabetes	Belgaum	Karnataka
India	Apex Research Center and Hospital	Bhopal	Madhya Pradesh
India	S P Medical College	Bikaner	Rajasthan
India	Baby Memorial Hospital	Calicut	Kerala
India	Frontier Lifeline	Chennai	Tamilnadu
India	Madras Diabetic Research Foundation	Chennai	Tamilnadu
India	Rajamuthaiah Hospital, Annamalianagar	Chennai	Tamilnadu
India	Sri Ramachandra Hospital	Chennai	Tamilnadu
India	Amrita Institute of medical Science	Cochin	Kerala
India	PSG Hospital	Coimbatore	Tamilnadu
India	Apollo Hospital	Hyderabad	Andhra Pradesh
India	Care Hospital, Banjarahills	Hyderabad	Andhra Pradesh
India	Care Hospital, Nampalli	Hyderabad	Andhra pradesh
India	Durga Bai Deshmuk Hospital	Hyderabad	Andhra Pradesh
India	Global hospital	Hyderabad	Andhra Pradesh
India	Mahavir Hospital	Hyderabad	Andhra Pradesh
India	MGM	Indore	Madhya Pradesh
India	Monilek Hospital	Jaipur	Rajasthan
India	Tongia Heart Hospital	Jaipur	Rajasthan
India	Peerless Hospital and BK Roy esearch Center	Kolkata	West Bengal
India	Vijaya Durga Cardiac Centre	Kurnool	Andhra Pradesh
India	Vijaya Hospital	Kurnool	Andhra Pradesh
India	King George Hospital	Lucknow	Uttar Pradesh
India	Sanjay Gandhi PGMI	Lucknow	Uttar Pradesh
India	Sidhu Hospital	Ludhiana	Punjab
India	Bhatia Hospital	Mumbai	Maharastra
India	C H L Apollo Hospital	Mumbai	Maharastra
India	Health Harmony Hospital	Mumbai	Maharastra
India	Vikaram Hospital and Health Care	Mysore	Karnataka
India	Avanti Institute of Cardiology	Nagpur	Maharastra
India	Cresent Hospital and Research center	Nagpur	Maharastra
India	Sri Ganga Ram Hospital	New Delhi	Delhi
India	Fortis Hospital	Noida	Delhi
India	Sadbhavana Heart Institute	Patiala	Punjab
India	Poona Hospital	Pune	Maharastra
India	Care Hospital	Secunderabad	Andhra Pradesh
India	Krishna Institute of Medical Sciences	Secunderabad	Andhra Pradesh
India	Nanjappa Hospital	Shimoga	Karnataka
India	West Fort Hospital	Thrissur	Kerala
India	Ramakrishna Nursing Home	Trichy	Tamilnadu
India	Kerala Institute of Medical sciences	Trivandrum	Kerala
India	Christian Medical College Hospital	Vellore	Tamil Nadu
India	Care Hospital	Vishakapatnam	Andhra Pradesh
India	Mahatma Gandhi Institute of Medical Sciences	Wardha	Maharastra

Sponsors (3)

Lead Sponsor	Collaborator
St. John's Research Institute	Cadila Pharnmaceuticals, Population Health Research Institute

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in blood Pressure		12 weeks	Yes
Primary	reduction in Heart Rate		12 weeks	Yes
Primary	modify lipids		12 weeks	Yes
Secondary	Platelet aggregation		12 weks	No

External Links

•   Cadila Pharmaceuticals
•   Division of Clinical Trials , St John's Research Institute, Website