Influence of Simvastatin on Apolipoprotein B-100 (apoB-100) Secretion
SVS
Influence of Simvastatin on apoB-100 Secretion in Non-Obese Subjects With Moderate Hypercholesterolemia: A Stable Isotope Study
1 other identifier
interventional
8
1 country
1
Brief Summary
3-Hydroxy-3-methylglutaryl coenzyme A-reductase inhibitors (statins) decrease apolipoprotein B-100-containing lipoproteins by increasing their fractional catabolic rates through low-density lipoproteins (LDL) receptor-mediated uptake. Their influence on hepatic secretion of these lipoproteins is controversial. The current study investigates whether simvastatin influences lipoprotein secretion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 1998
1 active site
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
November 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
May 18, 2009
CompletedFirst Posted
Study publicly available on registry
May 20, 2009
CompletedMay 20, 2009
May 1, 2009
4 months
May 18, 2009
May 18, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
apoB-100 kinetic parameters
One year
Secondary Outcomes (1)
Lipoprotein concentrations
One year
Study Arms (3)
No treatment
NO INTERVENTIONPhase A: No treatment
simvastatin chronic
EXPERIMENTALPhase B: 40 mg/day simvastatin
simvastatin acute-on-chronic
EXPERIMENTALPhase C: 80 mg simvastatin acute-on-chronic
Interventions
Eligibility Criteria
You may qualify if:
- Hypercholesterolemia
You may not qualify if:
- Obesity
- Treatment with lipid-lowering drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Bonn
Bonn, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heiner K. Berthold, MD, PhD
University of Bonn
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 18, 2009
First Posted
May 20, 2009
Study Start
November 1, 1998
Primary Completion
March 1, 1999
Study Completion
March 1, 2000
Last Updated
May 20, 2009
Record last verified: 2009-05