NCT00653744

Brief Summary

The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,700

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
12 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

March 26, 2008

Last Update Submit

March 13, 2009

Conditions

HypercholesterolemiaDyslipidaemia

Keywords

Cholesterollow density lipoproteinsdyslipidaemiaRosuvastatinCrestorAtorvastatinLipitorAfrican American

Outcome Measures

Primary Outcomes (1)

  • Low density lipoproteins cholesterol levels

    6 weeks

Secondary Outcomes (2)

  • Other blood lipid level changes

    6 weeks

  • Safety: adverse events & abnormal laboratory markers

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1
AtorvastatinDRUG
Also known as: Lipitor
2

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.
  • Self described African American race
  • 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

HypercholesterolemiaDyslipidemias

Interventions

Rosuvastatin CalciumAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Keith Ferdinand

    Heartbeats Life Centre, New Orleans, USA

    PRINCIPAL INVESTIGATOR

  • 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

March 26, 2008

First Posted

April 7, 2008

Study Start

March 1, 2002

Study Completion

March 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03