drugset / Trial / NCT02001883

Low-dose Statins and Nutraceuticals in High-intensity Statin-intolerant Patients

NCT02001883

Phase 4 Unknown 100 enrolled University of Roma La Sapienza
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of this study is to compare the efficacy and tolerability of low-dose statin therapy vs. the association between a low-dose statin and a nutraceutical-based protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at high-risk.

Timeline

Start
2013-11
Primary completion
2014-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule 5 mg
Comparator Atorvastatin Small molecule 10 mg
Comparator Berberine Traditional medicine (herbal / TCM) 500 mg
Comparator Policosanol Small molecule 10 mg
Comparator Simvastatin Small molecule 10 mg
Comparator Simvastatin Small molecule 20 mg
Comparator red yeast rice Traditional medicine (herbal / TCM) 200 mg