NCT00874757

Brief Summary

The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
1.6 years until next milestone

Study Start

First participant enrolled

November 15, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
13 years until next milestone

Results Posted

Study results publicly available

August 23, 2024

Completed
Last Updated

August 23, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

April 1, 2009

Results QC Date

September 15, 2017

Last Update Submit

March 28, 2024

Conditions

Healthy

Keywords

Statins, anti-inflammatoryHealthy subjects study

Outcome Measures

Primary Outcomes (1)

  • Toll-like Receptor 4 Expression Pre- and Post-Treatment

    Toll-like Receptor 4 (TLR-4) expression on monocytes in whole blood pre- and post- 3 weeks of rosuvastatin treatment.

    Before and after three weeks of treatment with rosuvastatin

Secondary Outcomes (3)

  • Tumor Necrosis Factor (TNF)

    Pre and post 3 weeks of rosuvastatin treatment

  • Interleukin-6

    Before (baseline) and after 3 weeks of rosuvastatin treatment

  • Interleukin-8

    measured in LPS treated blood before and after 3 weeks of Rosuvastatin treatment

Study Arms (1)

Rosuvastatin

Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre and post rosuvastatin treatment.

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

Healthy subjects received rosuvastatin 20 mg orally for 3 weeks. Inflammatory markers measured pre- and post- rosuvastatin treatment.

Also known as: Crestor
Rosuvastatin

Eligibility Criteria

Age19 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 healthy subjects

You may qualify if:

  • Healthy male non-asian subjects

You may not qualify if:

  • Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center, College of Pharmacy

Omaha, Nebraska, 68198-6045, United States

Location

Related Publications (5)

  • Wickelgren I. Immunology. Targeting the tolls. Science. 2006 Apr 14;312(5771):184-7. doi: 10.1126/science.312.5771.184. No abstract available.

    PMID: 16614188BACKGROUND

  • Falagas ME, Makris GC, Matthaiou DK, Rafailidis PI. Statins for infection and sepsis: a systematic review of the clinical evidence. J Antimicrob Chemother. 2008 Apr;61(4):774-85. doi: 10.1093/jac/dkn019. Epub 2008 Feb 7.

    PMID: 18263570BACKGROUND

  • Niessner A, Steiner S, Speidl WS, Pleiner J, Seidinger D, Maurer G, Goronzy JJ, Weyand CM, Kopp CW, Huber K, Wolzt M, Wojta J. Simvastatin suppresses endotoxin-induced upregulation of toll-like receptors 4 and 2 in vivo. Atherosclerosis. 2006 Dec;189(2):408-13. doi: 10.1016/j.atherosclerosis.2005.12.022. Epub 2006 Jan 26.

    PMID: 16443229BACKGROUND

  • Novack V, Eisinger M, Frenkel A, Terblanche M, Adhikari NK, Douvdevani A, Amichay D, Almog Y. The effects of statin therapy on inflammatory cytokines in patients with bacterial infections: a randomized double-blind placebo controlled clinical trial. Intensive Care Med. 2009 Jul;35(7):1255-60. doi: 10.1007/s00134-009-1429-0. Epub 2009 Feb 11.

    PMID: 19205663BACKGROUND

  • Wang CY, Liu PY, Liao JK. Pleiotropic effects of statin therapy: molecular mechanisms and clinical results. Trends Mol Med. 2008 Jan;14(1):37-44. doi: 10.1016/j.molmed.2007.11.004.

    PMID: 18068482BACKGROUND

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Timothy R McGuire
Organization
University of Nebraska Medical Center
trmcguir@unmc.edu
402-651-2496

Study Officials

  • Timothy R McGuire, PharmD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

November 15, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 23, 2024

Results First Posted

August 23, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)