Effect of an Internet Based Compliance Enhancement Tool in Subjects With Hypercholesterolemia

This study has been withdrawn prior to recruitment.

( Study cancelled prior to FSI )

First Received: October 16, 2005 Last Updated: March 25, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240357

Purpose

The purpose of the study is to determine whether an Internet based compliance tool is superior to common diet counselling in patients with hypercholesterolemia.

Condition	Intervention	Phase
Hypercholesterolemia	Procedure: Lifestyle Regulation	Phase IV

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary endpoint is the number and percentage of subjects from each group (rosuvastatin or rosuvastatin + a compliance enhancement tool) who reached the DSAM LDL-C target goal (LDL-C < 3.0 mmol/L) after 6 months therapy (24 weeks).

Secondary Outcome Measures:

Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy
Compliance with study drug assessed by tablet count data
Number and percentage of subjects increasing rosuvastatin dosage from 10 mg to 20 mg at week 12
Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24
Change in weight after 6 months therapy
Change in waistline after 6 months therapy

Estimated Enrollment:	1175
Study Start Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Available personal mailbox and access to the Internet
Primary hypercholesterolemia with CV risk > 20% over 10 years judged by the investigator or a history of ischemic heart disease or other established atherosclerotic disease (claudicatio intermittens, apoplexia cerebri (ischaemic stroke)) or stable diabetes mellitus
Fasting LDL-C level > 3.2 mmol/L

Exclusion Criteria:

Known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
Documented secondary hypercholesterolemia of any cause except stable diabetes mellitus (type 1 or type 2)
History of serious adverse effect or hypersensitivity reactions to statins, in particular any history of myopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240357

Show 109 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Denmark Medical Director, MD

AstraZeneca A/S

More Information

No publications provided

Study ID Numbers:	D3560L00002, Orbital
Study First Received:	October 16, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00240357 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Metabolic Disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009