NCT00654446

Brief Summary

The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
442

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 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

September 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
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

March 16, 2009

Status Verified

March 1, 2009

First QC Date

April 3, 2008

Last Update Submit

March 13, 2009

Conditions

Fredrickson Type IIa & Type IIb Dyslipidaemia

Keywords

Cholesterollow density lipoproteinsdyslipidaemiaRosuvastatinCrestorSimvastatinZocorRenalkidney

Outcome Measures

Primary Outcomes (1)

  • Development of Proteinuria

    2 weekly

Secondary Outcomes (3)

  • Renal effects of rosuvastatin and simvastatin

    2 weekly

  • Low density lipoproteins cholesterol levels

    2 weekly

  • Safety: adverse events & abnormal laboratory markers

    2 weekly

Study Arms (2)

1

EXPERIMENTAL

Rosuvastatin

Drug: Rosuvastatin

2

ACTIVE COMPARATOR

Simvastatin

Drug: Simvastatin

Interventions

RosuvastatinDRUG
Also known as: Crestor
1
SimvastatinDRUG
Also known as: Zocor
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.
  • 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 creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin CalciumSimvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Officials

  • Evan Stein

    Metabolic & Athersclerotic research centre, Cincinatti, 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

April 3, 2008

First Posted

April 8, 2008

Study Start

September 1, 2002

Study Completion

April 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03