NCT02023892

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

December 18, 2013

Last Update Submit

May 14, 2014

Conditions

EndotheliumHydroxymethylglutaryl-CoA Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

  • change of circulating endothelial microparticles

    from 1h to 24h after taking atorvastatin

Study Arms (2)

atorvastatin

EXPERIMENTAL

atorvastatin 20mg tablet, single dose of 80mg by mouth

Drug: atorvastatin

placebo

PLACEBO COMPARATOR

placebo 20mg tablet, single dose of 80mg by mouth

Drug: placebo

Interventions

atorvastatinDRUG
Also known as: Liptor
atorvastatin
placeboDRUG
Also known as: sugar pill manufactured to mimic atorvastatin 20mg tablet
placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy youth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AtorvastatinSugarsTablets

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsCarbohydratesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pharmacology, Zhongshan School of Medicine

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 30, 2013

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Last Updated

May 15, 2014

Record last verified: 2014-05