OLE Study to Evaluate Safety / Efficacy of ZD4522 | NCT00654303

Studies
OLE Study to Evaluate Safety / Efficacy of ZD4522

NCT00654303

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

3,500Estimated

Phase

Phase 3

Conditions

Hypercholesterolaemia

Interventions

Rosuvastatin

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
D3560C00034

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

Aug 1999

Primary Completion Date

Not provided

Completion Date

Feb 2005Actual

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 2, 2008

First Posted Date

Apr 7, 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

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

3,500Estimated

Label	Type	Description	Intervention Names
1	Experimental	Rosuvastatin	Drug: Rosuvastatin

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, as determined by adverse events, laboratory data, physical examination and ECG.		12 weekly

Secondary Outcomes

Measure	Description	Time Frame
Success in achieving goals for Cholesterol levels		12 weekly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completion of previous Crestor study as listed in the protocol.

Exclusion Criteria:

Pregnant or breast feeding women, or not using appropriate contraception.
Abnormal lab values as listed in the protocol.

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

Name	Affiliation	Role
Elinor Miller, MD	AstraZeneca	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	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