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C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients

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ClinicalTrials.gov Identifier: NCT00688454
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : April 9, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR

Condition or disease
Hypercholesteremia

Study Type : Observational
Actual Enrollment : 3392 participants
Time Perspective: Prospective
Official Title: C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients
Study Start Date : February 2007
Actual Study Completion Date : January 2008


Group/Cohort
Pt with hypercholesteremia
Patients treated with CRESTOR because of hypercholesteremia



Primary Outcome Measures :
  1. LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin [ Time Frame: 3 visits within 10 weeks ]

Secondary Outcome Measures :
  1. Tolerability of CRESTOR-therapy [ Time Frame: 3 visits within 10 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Statin-naive patients and unsuccessfully treated with other (non rosubastatin) statins patients
Criteria

Inclusion Criteria:

  • Patients with hypercholesteremia who was never treated with statins before
  • Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR

Exclusion Criteria:


Responsible Party: Dr med Madeleine Billeter, AstraZeneca AG, Switzerland
ClinicalTrials.gov Identifier: NCT00688454     History of Changes
Other Study ID Numbers: NIS-CCH-CRE-2007/1
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: April 9, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
Hyperlipidemia
Rosuvastatin
Efficacy
tolerability
CRESTOR therapy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors