A Swiss Study With Atorvastatin in Hyperlipidemic Patients Measuring LDL-Cholesterol - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00136942

Purpose

The proportion of patients achieving LDL-C target as defined by Swiss cholesterol recommendations (AGLA-recommendations) across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Atorvastatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, 6-Week-Treatment, Open-Label Study Assessing The Percentage Of Hyperlipidemic Patients Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The proportion of patients achieving LDL-C target as defined by local swiss AGLArecommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

Secondary Outcome Measures:

The proportion of patients across different AGLA-categories (primary and secondary prevention) achieving LDL-C target as defined by AGLA-recommendations across starting doses of 10 mg, 20 mg, 40 mg, and 80 mg of atorvastatin.

Estimated Enrollment:	370
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Risk factors and diagnosis of dyslipidemia according to the AGLA-recommendations (see appendix B) at screening
LDL-C < 6.0 mmol/l
Triglyceride level < 5.0 mmol/l.

Exclusion Criteria:

Subjects receiving higher than "usual maintenance" doses of Lipid Lowering Therapy (LLT) at screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136942

Locations

Switzerland, BE
Pfizer Investigational Site
Thun, BE, Switzerland
Pfizer Investigational Site
Langenthal, BE, Switzerland
Switzerland, BL
Pfizer Investigational Site
Binningen, BL, Switzerland
Pfizer Investigational Site
Liestal, BL, Switzerland
Switzerland, BS
Pfizer Investigational Site
Basel, BS, Switzerland
Pfizer Investigational Site
Basel, BS, Switzerland
Switzerland, FR
Pfizer Investigational Site
Duedingen, FR, Switzerland
Switzerland, GE
Pfizer Investigational Site
Onex, GE, Switzerland
Pfizer Investigational Site
Geneve, GE, Switzerland
Switzerland, SZ
Pfizer Investigational Site
Siebnen, SZ, Switzerland
Pfizer Investigational Site
Pfaeffikon, SZ, Switzerland
Switzerland, TI
Pfizer Investigational Site
Malvaglia, TI, Switzerland
Pfizer Investigational Site
Lugano, TI, Switzerland
Pfizer Investigational Site
Melide, TI, Switzerland
Pfizer Investigational Site
Vezia, TI, Switzerland
Pfizer Investigational Site
Lugano, TI, Switzerland
Switzerland, VD
Pfizer Investigational Site
Lausanne, VD, Switzerland
Pfizer Investigational Site
Prilly, VD, Switzerland
Pfizer Investigational Site
Ecublens, VD, Switzerland
Switzerland, ZG
Pfizer Investigational Site
Zug, ZG, Switzerland
Pfizer Investigational Site
Unteraegeri, ZG, Switzerland
Switzerland, ZH
Pfizer Investigational Site
Zuerich, ZH, Switzerland

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A2581089
Study First Received:	August 25, 2005
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00136942 History of Changes
Health Authority:	Switzerland: Swissmedic

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010