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OpenTrials
Completed

NCT Number: NCT00654602

48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety

The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.

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Key information

Conditions

Dyslipidaemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fasting low density lipoprotein level as defined by the protocol.
  • Fasting triglyceride level as defined by the protocol.

Exclusion criteria

  • The use of lipid lowering drugs or dietary supplements after Visit 1.
  • Active arterial disease eg Unstable angina, or recent arterial surgery.
  • Blood lipid levels above the limits defined in the protocol.
  • Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Treatment and study plan

Rosuvastatin

Drug

Other names: Crestor

Maintenance of specific diet

Behavioral

Primary outcomes

  1. Reduction in low density lipoprotein cholesterol levels

    Time frame: 12 weeks

Secondary outcomes

  1. Reduction in low density lipoprotein cholesterol levels

    Time frame: 24 & 48 weeks

  2. Safety: adverse events & abnormal laboratory markers

    Time frame: 4 weekly until week 12 then 12 weekly thereafter.

  3. Maintenance of lowered low density lipoprotein cholesterol level

    Time frame: Between week 12-48

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 48 Week, Open Label, Non-Comparative, Multicentre, Phase IIIb Study to Evaluate the Efficacy and Safety of the Lipid-Regulating Agent Rosuvastatin in the Treatment of Subjects With Fredrickson Type IIa and Type IIb Dyslipidaemia, Including Heterozygous Familial Hypercholesterolaemia.

Important dates

Study start
2002
Study completion
2004
First posted
Apr 8, 2008
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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