The Indian POLYCAP Study (TIPS)

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Ramipril plus atenolol plus thiazide; Drug: Thiazides; Drug: POLYCAP; Drug: Ramipril with Thiazide; Drug: Thiazide plus atenolol; Drug: Ramipril plus atenolol; Drug: Thiazide + Ramipril+Atenolol+Aspirin; Drug: Simvastatin; Drug: 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

Study Timeline

• Study First Submitted: 2007-02-14
• Study Start: 2007-03
• Study First Submitted QC: 2007-03-05
• Study First Posted: 2007-03-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-22
• Last Update Posted: 2010-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2050

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

• 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)

Aditya nursing Home; 🇮🇳 Adoni, Andhra pradesh, India

Gowri Gopal Nursing Home; 🇮🇳 Adoni, Andhra Pradesh, 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

Vijaya Durga Cardiac Centre; 🇮🇳 Kurnool, Andhra Pradesh, India

Vijaya Hospital; 🇮🇳 Kurnool, Andhra Pradesh, India

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