NCT00654407

Brief Summary

The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,875

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2001

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

November 1, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.6 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

Keywords

CholesterolhypercholesterolemiaCoronary Heart diseaselow density lipoproteinsRosuvastatinAtorvastatinsimvastatin

Outcome Measures

Primary Outcomes (1)

  • Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.

    16 weeks

Secondary Outcomes (3)

  • Percentage change in other cholesterol & triglyceride measures

    16 weeks

  • Safety evaluation

    8 & 16 weeks

  • To compare the efficacy of rosuvastatin with atorvastatin and simvastatin

Study Arms (3)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

3

ACTIVE COMPARATOR

Simvastatin

Drug: Simvastatin

Interventions

Also known as: Crestor
1
Also known as: Lipitor
2
Also known as: Zocor
3

Eligibility Criteria

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

You may qualify if:

  • Discontinuation of all cholesterol lowing drugs, including dietary supplements.
  • Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

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
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
  • Abnormal laboratory parameters as defined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ballantyne CM, Raichlen JS, Cain VA. Statin therapy alters the relationship between apolipoprotein B and low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol targets in high-risk patients: the MERCURY II (Measuring Effective Reductions in Cholesterol Using Rosuvastatin) trial. J Am Coll Cardiol. 2008 Aug 19;52(8):626-32. doi: 10.1016/j.jacc.2008.04.052.

MeSH Terms

Conditions

HypercholesterolemiaCoronary Disease

Interventions

Rosuvastatin CalciumAtorvastatinSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipidsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Officials

  • Joel Raichlen

    AstraZeneca

    STUDY DIRECTOR
  • Russell Esterline

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

November 1, 2001

Study Completion

September 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03