Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium "TIPSK"

Completed

Phase N/A Results

Trial Description

This is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL.
To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease.
Approximately 500 patients are planned to be randomized.

Detailed Description

Mean change in blood pressure between those taking 2capsules of the polycap versus one Difference in Rates of early discontinuation between 2 capsules of polycap versus one Rates of reported adverse effects among those taking the polycap

Conditions

Interventions

  • Indian Polycap Drug
    Other Names: Polycap; Polypill
    Intervention Desc: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
    ARM 1: Kind: Experimental
    Label: two doses of low strength polycap
    Description: Patients in this arm will receive 2 doses of low strength Polycap.
    ARM 2: Kind: Experimental
    Label: one dose of low srength polycap
    Description: Patients in this arm will receive one dose of low strength Polycap
  • Single Dose Polycap Drug
    Other Names: Polycap
    Intervention Desc: Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
    ARM 1: Kind: Experimental
    Label: SD Polycap without potassium
    Description: Single dose polycap without pottasium
  • Double dose Polycap Drug
    Other Names: Full dose polycap
    Intervention Desc: 2 Capsules of low strength polycap with 30mEq of Potassium
    ARM 1: Kind: Experimental
    Label: DD Polycap plus potassium
    Description: Double Dose polycap with potassium

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Is a double dose of polycap safe and effective in reducing blood pressure and controlling dyslipidemia among patients with history of cardiovascular event or uncontrolled type 2 diabetes. 8 weeks No
Secondary Blood pressure lowering effect of polycap in patients with type 2 diabetes mellitus 8 weeks No
Secondary Lipid lowering effect of polycap among patients with type 2 diabetes mellitus 8weeks No
Primary Blood pressure reduction and lowering of low density lipoprotein 8 weeks No
Primary Tolerability of a double dose of half strength polycap 8 weeks Yes
Secondary Blood pressure reduction and lipid lowering in Type 2 diabetics 8 weeks No
Primary BLOOD PRESSURE LIPIDS 8 weeks No

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