NCT00654602

Brief Summary

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 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

February 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
3.4 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

May 28, 2009

Status Verified

May 1, 2009

First QC Date

April 3, 2008

Last Update Submit

May 27, 2009

Conditions

Dyslipidaemia

Keywords

cholesterollow density lipoproteinsdyslipidaemiaRosuvastatinCrestor

Outcome Measures

Primary Outcomes (1)

  • Reduction in low density lipoprotein cholesterol levels

    12 weeks

Secondary Outcomes (3)

  • Reduction in low density lipoprotein cholesterol levels

    24 & 48 weeks

  • Safety: adverse events & abnormal laboratory markers

    4 weekly until week 12 then 12 weekly thereafter.

  • Maintenance of lowered low density lipoprotein cholesterol level

    Between week 12-48

Interventions

RosuvastatinDRUG
Also known as: Crestor
Maintenance of specific dietBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Fasting low density lipoprotein level as defined by the protocol.
  • Fasting triglyceride level as defined by 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.
  • 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

Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dr. Evan Stein

    Metabolic & Athersclerotic research centre, USA

    PRINCIPAL INVESTIGATOR

  • Russell Esterline

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 8, 2008

Study Start

February 1, 2002

Study Completion

November 1, 2004

Last Updated

May 28, 2009

Record last verified: 2009-05