NCT00654303

Brief Summary

The purpose of this study is to assess the long term safety of Crestor.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 1999

Longer than P75 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

August 1, 1999

Completed
5.5 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 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

April 2, 2008

Last Update Submit

March 13, 2009

Conditions

Hypercholesterolaemia

Keywords

CholesterolHypercholesterolaemiaStatins

Outcome Measures

Primary Outcomes (1)

  • Safety, as determined by adverse events, laboratory data, physical examination and ECG.

    12 weekly

Secondary Outcomes (1)

  • Success in achieving goals for Cholesterol levels

    12 weekly

Study Arms (1)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1

Eligibility Criteria

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

You may qualify if:

  • Completion of previous Crestor study as listed in the protocol.

You may not qualify if:

  • Pregnant or breast feeding women, or not using appropriate contraception.
  • Abnormal lab values as listed in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Elinor Miller, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

August 1, 1999

Study Completion

February 1, 2005

Last Updated

March 16, 2009

Record last verified: 2009-03