Rosuvastatin Efficacy and Safety Evaluation in Hyperchole... | NCT00695539

Studies
Rosuvastatin Efficacy and Safety Evaluation in Hypercholesterolaemic Patients

NCT00695539

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 5, 2009Estimated

Enrollment

810Actual

Phase

Not provided

Conditions

Hypercholesterolaemia

Interventions

Not provided

Countries

Greece

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

Status Module

Record Verification Date

Oct 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 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Actual

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 11, 2008

First Posted Date

Jun 12, 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

Oct 2, 2009

Last Update Posted Date

Oct 5, 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

This is a single-arm, phase IV, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 Greek subjects with hypercholesterolemia under normal clinical practice.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

810Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The assessment of rosuvastatin efficacy in the reduction of low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia at week 12 of treatment compared with baseline		At 12 weeks of treatment
To evaluate the percentage of patients on European LDL-C target at week 12		At 12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Changes in HDL-C, TC and TG		At week 12 & 24 of treatment
Safety and tolerability		Throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved SPC for no longer than 1 month prior to study entry
Patients that are able to read, understand and sign the Patient Information & Consent Form
Patients that are willing to comply with all study requirements

Exclusion Criteria:

Patients that are likely not to comply with all study requirements
Patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial
Female of child bearing potential that do not use a reliable method of contraception. Pregnancy or lactation.
Patients that meet any of the contraindications described in the approved SPC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Primary Care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alexandroupoli			Greece
Research Site

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