NCT00329173

Brief Summary

To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 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, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

May 22, 2006

Last Update Submit

March 13, 2009

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (1)

  • Reduction in LDL-c after 6 weeks

Secondary Outcomes (4)

  • Changes in other lipids and lipoproteins

  • Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C

  • Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.

  • Comparison of cost effectiveness and also safety

Interventions

RosuvastatinDRUG
AtorvastatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female 18 or over.
  • A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score \> 20% for CHD as described in NCEP ATP III guidelines1.

You may not qualify if:

  • History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
  • Pregnancy
  • History of homozygous familial hypercholesterolaemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Crestor Medical Science Director, MD

    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

May 22, 2006

First Posted

May 24, 2006

Study Start

November 1, 2003

Study Completion

August 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03