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

AstraZeneca logo

AstraZeneca

Status and phase

Withdrawn
Phase 4

Conditions

Hypercholesterolemia

Treatments

Procedure: Lifestyle Regulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240357
D3560L00002
Orbital

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

109

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Data sourced from clinicaltrials.gov

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