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

Phase 4

Withdrawn

• Conditions: Hypercholesterolemia

• Registration Number: NCT00240357
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-10-16
• Study First Submitted QC: 2005-10-16
• Study First Posted: 2005-10-18
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 1175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇩🇰 Ålestrup, Denmark