48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety | NCT00654602

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

NCT00654602

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

May 28, 2009Estimated

Enrollment

1,500Estimated

Phase

Phase 3

Conditions

Dyslipidaemia

Interventions

Rosuvastatin
Maintenance of specific diet

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

ID	Type	Description	Link
D3560C00091

Official Title

A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

Status Module

Record Verification Date

May 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

Not provided

Start Date

Feb 2002

Primary Completion Date

Not provided

Completion Date

Nov 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

May 27, 2009

Last Update Posted Date

May 28, 2009Estimated

Description Module

Brief Summary

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with 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

1,500Estimated

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin	Drug			Crestor
Maintenance of specific diet	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in low density lipoprotein cholesterol levels		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Reduction in low density lipoprotein cholesterol levels		24 & 48 weeks
Safety: adverse events & abnormal laboratory markers		4 weekly until week 12 then 12 weekly thereafter.

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 lipid levels above the limits defined in the protocol.
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
Dr. Evan Stein	Metabolic & Athersclerotic research centre, 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

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided