CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Valsartan +1 moredrug
Likely dose
Valsartan 320 mg orally dailyAI-extracted
Key inclusion· 4
  • Intima-media thickness of carotid artery >0.65 mm on ultrasound
  • Males aged 21–80 years, or women without child-bearing potential up to age 80
  • May continue stable concomitant aspirin, thiazide diuretics, calcium antagonists, or beta-blockers for hypertension
  • May remain on stable statin dose (unchanged for ≥2 months prior to enrollment)
Key exclusion· 12
  • ACE inhibitor or ARB use within previous 3 months
  • Initiation or change in statin dose within 2 months before study
  • Unable to return to Emory for follow-up blood draws and MR imaging
  • Premenopausal women with potential for pregnancy

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

Search/NCT00208767
NCT00208767Phase 2Completed

Effect of Valsartan on Endothelial Function, Oxidative Stress, Carotid Atherosclerosis, and Endothelial Progenitor Cells (EFFERVESCENT)

Emory University·interventional·Posted Sep 21, 2005·Updated Dec 8, 2015

In Brief

A Phase 2 clinical trial evaluating Valsartan and Placebo for Carotid Artery Diseases and Atherosclerosis. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The EFFERVESCENT trial is designed to evaluate the effects of a specific ARB, called valsartan, on atherosclerosis. The investigators want to know if treatment with valsartan will increase the blood levels of markers responsible for repair of the vessel wall, reduce oxidation and inflammation, improve the function of the blood vessels, and arrest or slow down the progression of atherosclerosis over time.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartFeb 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago

Interventions

Valsartandrug

Valsartan was titrated to a target dose of 320 mg orally daily

Placebodrug

A matched placebo pill will be given orally daily.