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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240357
First Posted: October 18, 2005
Last Update Posted: March 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240357


  Show 109 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Denmark Medical Director, MD AstraZeneca A/S
  More Information

ClinicalTrials.gov Identifier: NCT00240357     History of Changes
Other Study ID Numbers: D3560L00002
Orbital
First Submitted: October 16, 2005
First Posted: October 18, 2005
Last Update Posted: March 26, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases