drugset / Trial / NCT00693589

Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

NCT00693589

Phase 2 Completed 36 enrolled Insel Gruppe AG, University Hospital Bern
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Timeline

Start
2005-01
Primary completion
2007-02
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator B6 Other / unclassified 10 mg Oral
Comparator Rosuvastatin Small molecule 10 mg
Comparator Vitamin B12 Other / unclassified 0.4 mg Oral
Comparator folic acid Other / unclassified 1 mg Oral