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