Evaluate the Effects of High Dose Statin Therapy in Patients With Atherosclerotic Vascular Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00703261

Purpose

The purpose of this study is to see if a high dose of statin will reduce plaque in the body.

Condition	Intervention	Phase
Atherosclerotic Vascular Disease	Drug: atorvastatin Drug: placebo (unspecified)	Phase I

MedlinePlus related topics: Statins Vascular Diseases

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and Efficacy of the studied doses [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Optimal Dose in reducing plaque [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 10 mg atorvastatin + placebo	Drug: atorvastatin atorvastatin 10 mg; 80 mg atorvastatin Patients will be asked to self-administer these two tablets at approximately the same time each day. Drug: placebo (unspecified) placebo 10 mg; 80 mg placebo Patients will be asked to self-administer these two tablets at approximately the same time each day.
B: Active Comparator 80 mg atorvastatin + placebo	Drug: atorvastatin atorvastatin 10 mg; 80 mg atorvastatin Patients will be asked to self-administer these two tablets at approximately the same time each day. Drug: placebo (unspecified) placebo 10 mg; 80 mg placebo Patients will be asked to self-administer these two tablets at approximately the same time each day.

Eligibility

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

Criteria

Inclusion Criteria:

Male or Female ages 18 to 75
Patient is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening

Exclusion Criteria:

Patient has HIV, Hepatitis B or C
Patient uses illegal drugs
Patient has Type I diabetes
Patient has a history of claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703261

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Massachusetts
Call for Information	Recruiting
Newton, Massachusetts, United States, 02462
Call for Information	Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Call for Information	Recruiting
Troy, Michigan, United States, 48098
Call for Information	Recruiting
Royal Oak, Michigan, United States, 48703
United States, North Carolina
Call for Information	Recruiting
Statesville, North Carolina, United States, 28677
United States, Ohio
Call for Information	Recruiting
Cincinnati, Ohio, United States, 45219-0000

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_651, 081
Study First Received:	June 19, 2008
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00703261 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Arterial Occlusive Diseases
Atherosclerosis
Antilipemic Agents
Vascular Diseases

Anticholesteremic Agents
Arteriosclerosis
Fluorides
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Arteriosclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Atorvastatin

ClinicalTrials.gov processed this record on May 07, 2009