NCT00654537

Brief Summary

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,625

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 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

April 1, 2001

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.5 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

Hypercholesterolemia

Keywords

Cholesterolhypercholesterolemialow density lipoproteins

Outcome Measures

Primary Outcomes (1)

  • Percentage change in low density lipoprotein cholesterol.

    4 & 6 weeks

Secondary Outcomes (2)

  • Percentage change in other lipid parameters as defined by the protocol

    6 weeks

  • Safety evaluation

    6 weeks

Study Arms (4)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

3

ACTIVE COMPARATOR

Pravastatin

Drug: Pravastatin

4

ACTIVE COMPARATOR

Simvastatin

Drug: Simvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1
AtorvastatinDRUG
Also known as: Lipitor
2
PravastatinDRUG
Also known as: Lipostat
3
SimvastatinDRUG
Also known as: Zocor
4

Eligibility Criteria

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

You may qualify if:

  • Discontinuation of all previous lipid lowering therapy.
  • Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1.
  • Other lipid parameters as specified in the protocol.

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
  • Abnormal laboratory parameters as defined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin CalciumAtorvastatinPravastatinSimvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eleanor Miller, MD

    AstraZeneca

    STUDY DIRECTOR

  • Russell Esterline

    AstraZeneca

    STUDY CHAIR

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

April 1, 2001

Study Completion

October 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03