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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00688454

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Statins

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

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:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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

Responsible Party:	AstraZeneca AG, Switzerland ( Dr med Madeleine Billeter )
Study ID Numbers:	NIS-CCH-CRE-2007/1
Study First Received:	May 29, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00688454
Health Authority:	Switzerland: Ethikkommission

Keywords provided by AstraZeneca:

Hyperlipidemia
Rosuvastatin
Efficacy
tolerability
CRESTOR therapy

Study placed in the following topic categories:

Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009