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Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS) (HEROS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660764
First Posted: April 17, 2008
Last Update Posted: March 16, 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
In an observational multi-centre study (HEROS), the effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who had not been treated with cholesterol lowering drugs at least in the past three months. Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.

Condition Intervention
Hypercholesterolemia Coronary Heart Disease Peripheral Vascular Disease Cerebrovascular Accident Diabetes Drug: Rosuvastatin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Efficacy of Rosuvastatin in Patient Groups With a Dissimilar Risk Profile in an Observational Study (HEROS)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Effects of starting treatment with rosuvastatin were assessed, on low-density lipoprotein cholesterol (LDL-C) goal achievement, in patients with a dissimilar high-risk profile who hadn't been treated with cholesterol lowering drugs in the past 3 months. [ Time Frame: 2 year ]

Secondary Outcome Measures:
  • Also set-up costs of rosuvastatin treatment and proportional changes in LDL-C and high-density lipoprotein cholesterol (HDL-C) were studied.

Study Start Date: May 2003
Study Completion Date: April 2005
Groups/Cohorts Assigned Interventions
1
Patients eligible for the study were patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C ≥ 3.2 mmol/l. Patients were aged ≥ 18 years and ≤ 70 years (men) and ≤ 75 years (women), according to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention. The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation. Patient approved to place anonymous results at the disposal of AstraZeneca
Drug: Rosuvastatin
Oral
Other Name: Crestor

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of practices of General Practioners
Criteria

Inclusion Criteria:

  • patients who had not been treated with cholesterol lowering drugs at least in the past three months, with an LDL-C 3.2 mmol/l.
  • According to the advise of the CBO, and could be included in one of the following risk groups: secondary prevention, DM or primary prevention.
  • The general practice investigator made the decision to start treatment with rosuvastatin irrespective of study participation.
  • Patient approved to place anonymous results at the disposal of AstraZeneca

Exclusion Criteria:

  • Patients with symptoms of myalgia, myopathy or liver function insufficiency (including raised serum transaminases) which bear a causal relation to the treatment with statins, patients with familiar dyslipidemia and/or patients with contra-indications for treatment with rosuvastatin
  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): NCT00660764


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

Responsible Party: Elisabeth Björk - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660764     History of Changes
Other Study ID Numbers: 25V07
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
cholesterol
coronary heart disease
rosuvastatin
LDL-C goal
hypercholesterolemia
secondary prevention
primary prevention
CVA

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