NCT00654446

CompletedPhase 3

IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastati...

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

4522IL/0099

Study Type

interventional

Reported enrollment (type unavailable)

442

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

April 2004

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 442 participants
Study completion date: April 2004
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
April 2004
Actual (reported)
First Submitted
April 3, 2008
Actual (reported)
First Posted
April 8, 2008
Actual (reported)

Last Updated: March 16, 2009
Status Verified: March 2009
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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:

Sponsors & Collaborators

AstraZeneca
Industrylead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Rosuvastatin CalciumSimvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, Halogenated

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

April 2004

Actual (reported)

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Phase 3Terminated

NCT00241488

DISCOVERY Asia - Crestor in Type IIa and IIb Hypercholesteremia

Phase 3Completed

NCT00800800

Effects of Rosuvastatin on Aortic Stenosis Progression

Phase 3Completed

NCT00525824

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

Phase 3Completed

NCT00654602

48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

Phase 3Completed

NCT00240292

Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines

Phase 3Completed

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.

Hydrocarbons

Sulfones

Sulfur Compounds

Pyrimidines

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

Lovastatin

Naphthalenes

Polycyclic Aromatic Hydrocarbons

Hydrocarbons, Aromatic

Hydrocarbons, Cyclic

Polycyclic Compounds

Last Updated

March 16, 2009

Record last verified: 2009-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00654446
Data provider: ClinicalTrials.gov
Source updated: 2009-03-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:08 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record