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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688454
First received: May 29, 2008
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Hypercholesteremia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin [ Time Frame: 3 visits within 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of CRESTOR-therapy [ Time Frame: 3 visits within 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 3392
Study Start Date: February 2007
Study Completion Date: January 2008
Groups/Cohorts
Pt with hypercholesteremia
Patients treated with CRESTOR because of hypercholesteremia

  Eligibility

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: May 29, 2008
Last Updated: April 8, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by AstraZeneca:
Hyperlipidemia
Rosuvastatin
Efficacy
tolerability
CRESTOR therapy

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

ClinicalTrials.gov processed this record on May 23, 2013