IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvast... | NCT00654446

Studies
IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

NCT00654446

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

442

Phase

Phase 3

Conditions

Fredrickson Type IIa & Type IIb Dyslipidaemia

Interventions

Rosuvastatin
Simvastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Not provided

Completion Date

Apr 2004Actual

First Submitted Date

Apr 3, 2008

First Submission Date that Met QC Criteria

Apr 3, 2008

First Posted Date

Apr 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2009

Last Update Posted Date

Mar 16, 2009Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

442

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Rosuvastatin	Drug: Rosuvastatin
2	Active Comparator	Simvastatin	Drug: Simvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug		1	Crestor
Simvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of Proteinuria		2 weekly

Secondary Outcomes

Measure	Description	Time Frame
Renal effects of rosuvastatin and simvastatin		2 weekly
Low density lipoproteins cholesterol levels		2 weekly
Safety: adverse events & abnormal laboratory markers

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evan Stein	Metabolic & Athersclerotic research centre, Cincinatti, USA	Principal Investigator
Russell Esterline	AstraZeneca	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium
D019821	Simvastatin

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided