CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 518 enrolled
Drug / intervention
Single Dose Polycap +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01404078
NCT01404078N/ACompleted
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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

St. John's Research Institute·interventional·Posted Jul 27, 2011·Updated Dec 1, 2014

In Brief

A clinical study evaluating Single Dose Polycap and Double dose Polycap for Ischemic Heart Disease and 3 related conditions. Completed, enrolled 518 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus
Countries--
CollaboratorsPopulation Health Research Institute

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2011
Enrollment StartApr 1, 2010
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.9 years ago

Interventions

Single Dose Polycapdrug

Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin

Double dose Polycapdrug

2 Capsules of low strength polycap with 30mEq of Potassium