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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
518
Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
2 Capsules of low strength polycap with 30mEq of Potassium
BLOOD PRESSURE LIPIDS
Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.
Time frame: 8 weeks
Tolerability of a Double Dose of Half Strength Polycap
Time frame: 8 weeks
Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics
Time frame: 8 weeks
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