NCT01011127

Brief Summary

The investigators hypothesize that pravastatin and rosuvastatin may have different 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 Dec 2009

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

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 5, 2010

Status Verified

October 1, 2010

Enrollment Period

7 months

First QC Date

November 10, 2009

Last Update Submit

October 4, 2010

Conditions

Hypercholesterolemia

Keywords

StatinsInsulin resistance

Study Arms (2)

pravastatin

Drug: pravastatin, rosuvastatin

rosuvastatin

Drug: pravastatin, rosuvastatin

Interventions

pravastatin, rosuvastatinDRUG
pravastatinrosuvastatin

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hypercholesterolemia

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, 405-760, 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: 10205010BACKGROUND

MeSH Terms

Conditions

HypercholesterolemiaInsulin Resistance

Interventions

PravastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

October 5, 2010

Record last verified: 2010-10

Locations

KR(1)