Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00396110
First received: November 3, 2006
Last updated: NA
Last verified: February 2003
History: No changes posted
  Purpose
In this study the effect of the switch to rosuvastatin from another statin (fluvastatin, pravastatin, simvastatin, atorvastatin) was evaluated in high-risk patients with and without evident CHD and LDL-C ≥ 3.2 mmol/l. This was done in a large observational study (TARGET) representing daily practice. Primary end points analysis was the percentage of patients reaching the target of LDL-C < 3.2 mmol/l. Secondary outcomes were the changes of LDL-C, HDL-C, TC, Triglycerides (TG) and TC/HDL-C-ratio from baseline.

Condition Phase
Hypercholesterolemia
Coronary Heart Disease
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Evaluation of the Efficacy of Rosuvastatin in Daily Practice (TARGET)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 3889
Study Start Date: February 2003
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High-risk patients with and without evident CHD who had LDL-C > 3.2 mmol/l and were treated at that moment with HMG-CoA-reductase inhibitor apart from rosuvastatin.
  • Patients were aged >18 years and <70 years (men) and < 75 years (women).

Exclusion Criteria:

  • Treatment with atorvastatin 40 or 80 mg or simvastatin 80 mg
  • Patients familiar with muscular pain, myopathy or liver function disorders (inclusive elevation of serum transaminases) and/or contra-indications for treatment with rosuvastatin
  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: NCT00396110

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Ingrid van Geel, MD AstraZeneca
Study Chair: Ingeborg Vosjan, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00396110     History of Changes
Other Study ID Numbers: 25V06  TARGET 
Study First Received: November 3, 2006
Last Updated: November 3, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:
cholesterol
coronary heart disease
rosuvastatin
LDL-C goal
hypercholesterolemia

Additional relevant MeSH terms:
Heart Diseases
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on December 02, 2016