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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This study has been withdrawn prior to enrollment.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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00240357
First received: October 16, 2005
Last updated: March 25, 2009
Last verified: March 2009
  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
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014