NCT01404078

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

A RCT With Factorial Design to Compare Safety and Efficacy of 2 Capsules of the Indian Polycap Versus a Single Capsule Along With or Without Oral Potassium Among Patients With Stable Cardiovascular Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: St. John's Research Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ischemic Heart Disease
• Ischemic Stroke
• Peripheral Vascular Disease
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Single Dose Polycap	Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
DRUG	Double dose Polycap	2 Capsules of low strength polycap with 30mEq of Potassium

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-07-27
• Last updated: 2014-12-01
• Results posted: 2014-12-01