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

Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240357

Enrollment

1175

Registered

2005-10-18

Start date

2003-02-28

Completion date

Unknown

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

PROCEDURELifestyle Regulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—
Number and percentage of subjects within the DSAM LDL-C target goal after 3 months therapy	—
Change in weight after 6 months therapy	—
Change in waistline after 6 months therapy	—
Percentage change in TC, HDL-C, LDL-C, TG from week 0 to week 24	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026