The Indian POLYCAP Study (TIPS)

Completed

Phase N/A Results

Trial Description

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.

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: Capsule (Blinded) for oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 8,H
    Description: Lipid lowering agent
  • Atenolol (Tenormin)Drug
    Other Names: tenormin
    Intervention Desc: Beta-adrenergic receptor antagonist (beta-blocker); anti-hypertensive
  • Ramipril (Altace®)Drug
    Intervention Desc: Ramipril is used alone or in combination with other medications to treat high blood pressure. It is also used to reduce the risk of heart attack and stroke in patients at risk for these problems and to improve survival in patients with heart failure after a heart attack. Ramipril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: capsule (Blinded) for oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 9,A
    Description: Antiplatelet
  • POLYCAP Drug
    Intervention Desc: Capsule for Oral Administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 1, POLYCAP
    Description: Combination of 3 anti hypertensives, lipid lowering agent and anti platelet agent
  • Thiazides Drug
    Intervention Desc: Capsule (blinded) oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 2 B
    Description: Diuretic antihypertensive
  • Ramipril with Thiazide Drug
    Intervention Desc: Capsule (blinded) oral administration 12 weeks
    ARM 1: Kind: Experimental
    Label: 3 C
    Description: Thiazide plus Angiotensis converting enzyme inhibitor - combination antihypertensive.
  • Thiazide plus atenolol Drug
    Intervention Desc: Caspule (blinded) for oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 4 D
    Description: Diuretic with Beta blocker combination antihypertensive
  • Ramipril plus atenolol Drug
    Intervention Desc: Capsule ( blinded) for oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 5, E
    Description: ACE inhibitor plus Beta blocker combination antihypertensive
  • Ramipril plus atenolol plus thiazide Drug
    Intervention Desc: Capsule (blinded) for oral administration once daily for 12 weeeks
    ARM 1: Kind: Experimental
    Label: 6, F
    Description: Combination antihypertensive of ACE inhibitor, diuretic and beta blocker
  • Thiazide + Ramipril+Atenolol+Aspirin Drug
    Intervention Desc: Capsule (Blinded) for oral administration once daily for 12 weeks
    ARM 1: Kind: Experimental
    Label: 7,G
    Description: Combination of ACE inhibitor, betablocker, diuretic and Antiplatelet

Trial Design

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

Patient Involvement

Patients will be randomized to one of 9 arms and receive POLYCAP® or its comparators. Subjects will take study medication for 3 months. There will be five follow up visits, the first 7 - 10 days after starting study medication and thereafter monthly visits (from starting meds)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. Subjects will be evaluated for mean difference of change in BP, LDL and urinary thromboxane at the end of the three month period.

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduction in blood Pressure, reduction in Heart Rate, and modify lipids
Secondary Platelet aggregation.
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

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