NCT00654485

Brief Summary

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
940

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2002

Typical duration for phase_3

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

May 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2008

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

April 3, 2008

Last Update Submit

March 13, 2009

Conditions

Metabolic Syndrome

Keywords

Cholesterolhypercholesterolemialow density lipoproteinsmetabolic syndromeRosuvastatin

Outcome Measures

Primary Outcomes (1)

  • Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome.

    At 6 & 12 weeks

Secondary Outcomes (3)

  • Modification of other lipids and lipoproteins

    At 6 & 12 weeks

  • Modification of insulin resistance, inflammatory markers & glucose metabolism

    At 6 & 12 weeks

  • Safety: adverse events & abnormal laboratory markers

    At 6 & 12 weeks

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1
AtorvastatinDRUG
Also known as: Lipitor
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
  • Fasting low density lipoprotein cholesterol level of \> 130 mg/dL.
  • Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
  • Not previously taken statins.

You may not qualify if:

  • The use of lipid lowering drugs or dietary supplements after Visit 1
  • Active arterial disease eg Unstable angina, or recent arterial surgery
  • Blood lipid levels above the limits defined in the protocol
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeHypercholesterolemia

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Prof. Anton Stalenhoef

    University Medical Centre, The Netherlands

    PRINCIPAL INVESTIGATOR

  • Russell Esterline

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

May 1, 2002

Study Completion

February 1, 2005

Last Updated

March 16, 2009

Record last verified: 2009-03