NCT00317993

Brief Summary

The purpose of this study is to investigate the effects of the two lipid -lowering drugs, ezetimibe and simvastatin, on lipid metabolism in humans. In specific, the study will investigate in blood cells whether the enzyme that controls cholesterol synthesis, HMG-CoA reductase, and the receptor that takes up cholesterol from the blood, the LDL receptor, are changed during treatment with the aforementioned drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_4

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

April 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2006

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

April 24, 2006

Last Update Submit

December 2, 2014

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (4)

  • HMG-CoA reductase activity

  • HMG-CoA reductase mRNA expression

  • LDL receptor mRNA expression

  • LDL receptor protein

Interventions

ezetimibeDRUG
simvastatinDRUG
ezetimibe plus simvastatinDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • age between 18 and 60 years
  • body mass index between 18.5 and 30 kg/m2
  • LDL cholesterol smaller than 190 mg/dL
  • triglicerides smaller than 250 mg/dL
  • normal blood pressure

You may not qualify if:

  • intake of lipid-lowering drugs
  • excessive alcohol intake
  • liver disease
  • kidney disease
  • coronary heart disease
  • eating disorders
  • diabetes or other endocrine disorders
  • medications that interfere with lipid metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik II und Poliklinik für Innere Medizin

Cologne, 50924, Germany

Location

Related Publications (5)

  • Berthold HK, Rizzo M, Spenrath N, Montalto G, Krone W, Gouni-Berthold I. Effects of lipid-lowering drugs on high-density lipoprotein subclasses in healthy men-a randomized trial. PLoS One. 2014 Mar 24;9(3):e91565. doi: 10.1371/journal.pone.0091565. eCollection 2014.

    PMID: 24662777DERIVED

  • Gouni-Berthold I, Berthold HK, Huh JY, Berman R, Spenrath N, Krone W, Mantzoros CS. Effects of lipid-lowering drugs on irisin in human subjects in vivo and in human skeletal muscle cells ex vivo. PLoS One. 2013 Sep 2;8(9):e72858. doi: 10.1371/journal.pone.0072858. eCollection 2013.

    PMID: 24023786DERIVED

  • Berthold HK, Seidah NG, Benjannet S, Gouni-Berthold I. Evidence from a randomized trial that simvastatin, but not ezetimibe, upregulates circulating PCSK9 levels. PLoS One. 2013;8(3):e60095. doi: 10.1371/journal.pone.0060095. Epub 2013 Mar 27.

    PMID: 23544125DERIVED

  • Berthold HK, Berneis K, Mantzoros CS, Krone W, Gouni-Berthold I. Effects of simvastatin and ezetimibe on interleukin-6 and high-sensitivity C-reactive protein. Scand Cardiovasc J Suppl. 2013 Feb;47(1):20-7. doi: 10.3109/14017431.2012.734635. Epub 2012 Oct 18.

    PMID: 23013513DERIVED

  • Berneis K, Rizzo M, Berthold HK, Spinas GA, Krone W, Gouni-Berthold I. Ezetimibe alone or in combination with simvastatin increases small dense low-density lipoproteins in healthy men: a randomized trial. Eur Heart J. 2010 Jul;31(13):1633-9. doi: 10.1093/eurheartj/ehq181. Epub 2010 Jun 6.

    PMID: 20525999DERIVED

MeSH Terms

Interventions

EzetimibeSimvastatin

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ioanna Gouni-Berthold, MD

    Medizinische Klinik II und Poliklinik für Innere Medizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2006

First Posted

April 25, 2006

Study Start

April 1, 2004

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

DE(1)