CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 10 mg orally daily for 12 weeks or Pravastatin 80 mg orally daily for 12 weeksAI-extracted
Key inclusion· 5
  • Age 21–80 years
  • LDL cholesterol >120 mg/dL
  • Either diabetic or ≥3 components of metabolic syndrome (hypertension, fasting glucose >110 mg/dL, increased waist circumference, triglycerides >150 mg/dL, or low HDL)
  • Non-smoker
Key exclusion· 13
  • Age <21 or >80 years
  • Premenopausal females with potential for pregnancy
  • LDL cholesterol <120 mg/dL
  • On any oral antioxidants or lipid-lowering medications in the previous 8 weeks

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

Search/NCT00166036
NCT00166036Phase 2Completed

Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells: Comparison of Atorvastatin With Pravastatin

Emory University·interventional·Posted Sep 14, 2005·Updated Sep 8, 2014

In Brief

A Phase 2 clinical trial evaluating Atorvastatin and Pravastatin for Diabetes Mellitus and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartSep 1, 2004
Primary CompletionMar 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.8 years ago

Interventions

Atorvastatindrug

12 Weeks of Oral Atorvastatin 10 mg therapy.

Pravastatindrug

12 Weeks of Oral Pravastatin 80 mg therapy.