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

This study has been withdrawn prior to enrollment.
(Study cancelled prior to FSI)
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 16, 2005
Last updated: March 25, 2009
Last verified: March 2009

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
Procedure: Lifestyle Regulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement of LDL Goals. - Denmark

Resource links provided by NLM:

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

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

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
Study Director: AstraZeneca Denmark Medical Director, MD AstraZeneca A/S
  More Information

No publications provided

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

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014