NCT00546559

Brief Summary

The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2004

Longer than P75 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

Study Start

First participant enrolled

January 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

First QC Date

October 18, 2007

Last Update Submit

August 28, 2008

Conditions

Hypercholesterolemia

Keywords

Lipophilic statinsInsulin resistancesimvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.

Outcome Measures

Primary Outcomes (1)

  • Simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.

Interventions

statins (simvastatin, pravastatin)DRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low-density lipoprotein cholesterol levels \> 130

You may not qualify if:

  • Overt liver disease,
  • Chronic renal failure
  • Hypothyroidism
  • Myopathy
  • Uncontrolled diabetes
  • Severe hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center

Incheon, 405760, South Korea

Location

Related Publications (1)

  • Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.

    PMID: 10205010RESULT

MeSH Terms

Conditions

HypercholesterolemiaInsulin Resistance

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsSimvastatinPravastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Kwang K Koh, MD,PhD

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 19, 2007

Study Start

January 1, 2004

Study Completion

March 1, 2008

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

KR(1)