NCT00240266

Brief Summary

The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

November 19, 2010

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

October 16, 2005

Last Update Submit

November 18, 2010

Conditions

Metabolic SyndromeDyslipidemia

Keywords

Metabolic SyndromeDyslipaemia

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Secondary Outcomes (5)

  • Determine the effect of treatment with rosuvastatin on:

  • - cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT.

  • - plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT.

  • - plasma concentration of preβ1-HDL.

  • - plasma concentration of LDL cholesterol, HDL-C and apoA-1.

Interventions

RosuvastatinDRUG
Also known as: Crestor

Eligibility Criteria

Age45 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • males aged 45-65
  • insulin resistance
  • central obesity
  • LDL-C \<6 mmol/L
  • plasma triglycerides \>=1.7 and ≤5.5 mmol/L
  • HDL-C ≤1.2 mmol/L.

You may not qualify if:

  • total cholesterol \>7mmol/L
  • pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul J Nestel, MD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2005

First Posted

October 18, 2005

Study Start

August 1, 2003

Primary Completion

November 1, 2004

Study Completion

December 1, 2004

Last Updated

November 19, 2010

Record last verified: 2010-11

Locations

AU(1)