NCT00309374

Brief Summary

The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor pretreatment on inflammation and coagulation activation in human endotoxemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

March 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 5, 2007

Status Verified

January 1, 2007

First QC Date

March 30, 2006

Last Update Submit

January 4, 2007

Conditions

Endotoxemia

Keywords

LPSStatinsleukocyte mRNA expression profiles

Outcome Measures

Primary Outcomes (2)

  • monocyte CRP production

  • leukocyte mRNA expression profiles (human genome GeneChip arrays)

Secondary Outcomes (4)

  • various inflammation and coagulation parameters

  • platelets

  • endothelial progenitor cells

  • adverse events

Interventions

LPS 2ng/kg intravenous bolusDRUG
Simvastatin 80mg; administered daily p.o. over 5 daysDRUG
Rosuvastatin 40mg; administered daily p.o. over 5 daysDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged between 18 and 45 years
  • Nonsmokers or smokers \<5 cig/d
  • Body mass index between 18 and 30; respectively weight ≤ 95 kilograms
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

You may not qualify if:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
  • Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia
  • Treatment in the previous 3 weeks with any drug
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • History of hypersensitivity to the trial drug or to drugs with a similar chemical structure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Dept. of Clinical Pharmacology

Vienna, Vienna, Austria

Location

Related Publications (3)

  • Steiner S, Speidl WS, Pleiner J, Seidinger D, Zorn G, Kaun C, Wojta J, Huber K, Minar E, Wolzt M, Kopp CW. Simvastatin blunts endotoxin-induced tissue factor in vivo. Circulation. 2005 Apr 12;111(14):1841-6. doi: 10.1161/01.CIR.0000158665.27783.0C.

    PMID: 15824212BACKGROUND

  • Pernerstorfer T, Hollenstein U, Hansen J, Knechtelsdorfer M, Stohlawetz P, Graninger W, Eichler HG, Speiser W, Jilma B. Heparin blunts endotoxin-induced coagulation activation. Circulation. 1999 Dec 21-28;100(25):2485-90. doi: 10.1161/01.cir.100.25.2485.

    PMID: 10604885BACKGROUND

  • Spiel AO, Mayr FB, Leitner JM, Firbas C, Sieghart W, Jilma B. Simvastatin and rosuvastatin mobilize Endothelial Progenitor Cells but do not prevent their acute decrease during systemic inflammation. Thromb Res. 2008;123(1):108-13. doi: 10.1016/j.thromres.2008.03.007. Epub 2008 Apr 22.

    PMID: 18433844DERIVED

MeSH Terms

Conditions

Endotoxemia

Interventions

Lipopolysaccharides

Condition Hierarchy (Ancestors)

BacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigensBiological FactorsEndotoxinsBacterial ToxinsToxins, Biological

Study Officials

  • Michael Wolzt, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

March 1, 2006

Study Completion

July 1, 2006

Last Updated

January 5, 2007

Record last verified: 2007-01

Locations

AU(1)