Single Dose of Atorvastatin and Circulating Endothelial Microparticles

May 14, 2014 updated by: Yi-jun Huang, PhD, Sun Yat-sen University

The Effect of Single Dose of Atorvastatin on Change of Circulating Endothelial Microparticles

Healthy subjects take single dose of 80mg atorvastatin, then measured their circulating endothelial microparticles and flow-mediated vasodilation in the brachial artery by ultrasound at different time points.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy youth

Exclusion Criteria:

  • acute pathologies
  • familial history of cardiovascular disease
  • smoking or drinking alcohol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: atorvastatin
atorvastatin 20mg tablet, single dose of 80mg by mouth
Drug: atorvastatin
Other Names:
  • Liptor
Placebo Comparator: placebo
placebo 20mg tablet, single dose of 80mg by mouth
Drug: placebo
Other Names:
  • sugar pill manufactured to mimic atorvastatin 20mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of circulating endothelial microparticles
Time Frame: from 1h to 24h after taking atorvastatin
from 1h to 24h after taking atorvastatin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 24, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YHuang002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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