Conditions: Ischemic Heart Disease Ischemic Stroke Peripheral Vascular Disease Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 518
Healthy volunteers: no

Brief summary:
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

Arms:
arm 1: Single dose polycap without pottasium arm 2: Double Dose polycap with potassium

Interventions: intervention 1: Single Dose Polycap intervention 2: Double dose Polycap
Intervention descriptions: intervention 1: Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin intervention 2: 2 Capsules of low strength polycap with 30mEq of Potassium

Protocol document: