Evaluation of Effects of Rosuvastatin 40mg on Myocardial... | NCT00657527

Studies
Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease

NCT00657527

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

280Estimated

Phase

Phase 3

Conditions

Myocardial Ischaemia
Coronary Artery Disease

Interventions

Rosuvastatin
Cholesterol lowering 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
D3560C00043

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

Dec 2001

Primary Completion Date

Not provided

Completion Date

Dec 2002Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 8, 2008

First Posted Date

Apr 14, 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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.

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

280Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Rosuvastatin	Drug: Rosuvastatin
2	No Intervention	Diet	Behavioral: Cholesterol lowering diet

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.		8 weekly

Secondary Outcomes

Measure	Description	Time Frame
Change in duration of ischemic episodes		8 weekly
Safety		8 weekly
Several laboratory parameters as detailed in the protocol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of Coronary arterial disease
Suffering ischaemic episodes/exercise induced ischaemia
Not taking any cholesterol lowering medication

Exclusion Criteria:

Unstable angina or heart attack less than one month before trial entry
Coronary arterial surgery as defined by protocol
Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Cressman, DO	AstraZeneca	Study Director
Russell Esterline	AstraZeneca	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular 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