The purpose of this study is to determine if patients who are already taking atorvastatin, but still have moderately high blood cholesterol, could lower their cholesterol further by co-administration with TAK-475.

Condition	Intervention	Phase
Hyperlipidemia Hypercholesterolemia	Drug: TAK-475	Phase III

Further Study Details: 

Primary Outcomes: The primary endpoint will be change in fasting LDL-C at 24 weeks.
Expected Total Enrollment:  420

The purpose of this study is to evaluate the efficacy and safety of TAK-475 (2 doses) compared to placebo when co-administered with atorvastatin in subjects with primary hypercholesterolemia. Subjects who have been taking a stable dose of atorvastatin for at least 4 weeks will undergo necessary evaluations to determine eligibility for a Run-In period. During the Run-In, subjects will continue to receive atorvastatin. Subjects who meet randomization criteria will be treated with one of the following randomized treatment groups: TAK-475 (1 of 2 doses) or placebo while maintaining the Run-In dose of atorvastatin.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female who is at least 18 years of age.
• The subject must have a normal physical examination and normal laboratory results at screening.
• The subject must have been taking the same daily dose of atorvastatin for at least 4 weeks prior to starting the study.
• The subject must have 2 blood draws at least one week apart whose results demonstrate hypercholesterolemia.

Exclusion Criteria:

• Subject with diabetes whose HbA1c > 8%.
• Subject has elevated ALT, AST, CPK, and serum creatinine above the pre-specified criteria.
• Subject has blood pressure over 160/100. Taking stable medication for high blood pressure is allowed.
• Subject had heart problems in the prior 6 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00143676

Clement Popovici, MS      847-383-3469    cpopovici@tgrd.com

Alabama
      Birmingham,  Alabama,  United States; Recruiting
      Northport,  Alabama,  United States; Recruiting
Arizona
      Sierra Vista,  Arizona,  United States; Recruiting
      Tucson,  Arizona,  United States; Recruiting
Arkansas
      Jonesboro,  Arkansas,  United States; Recruiting
      Searcy,  Arkansas,  United States; Recruiting
California
      Anaheim,  California,  United States; Recruiting
      Carmichael,  California,  United States; Recruiting
      Escondido,  California,  United States; Recruiting
      Pismo Beach,  California,  United States; Recruiting
      Santa Rosa,  California,  United States; Recruiting
      Chula Vista,  California,  United States; Recruiting
Colorado
      Golden,  Colorado,  United States; Recruiting
Connecticut
      Waterbury,  Connecticut,  United States; Recruiting
Florida
      Clearwater,  Florida,  United States; Recruiting
      Daytona Beach,  Florida,  United States; Recruiting
      Hollywood,  Florida,  United States; Recruiting
      Jacksonville,  Florida,  United States; Recruiting
      Jupiter,  Florida,  United States; Recruiting
      Kissimmee,  Florida,  United States; Recruiting
      Miami,  Florida,  United States; Recruiting
      New Port Richey,  Florida,  United States; Recruiting
      Ocala,  Florida,  United States; Recruiting
      Pembroke Pines,  Florida,  United States; Recruiting
      West Palm Beach,  Florida,  United States; Recruiting
Hawaii
      Honolulu,  Hawaii,  United States; Recruiting
Illinois
      Arlington Heights,  Illinois,  United States; Recruiting
      Chicago,  Illinois,  United States; Recruiting
      Peoria,  Illinois,  United States; Recruiting
Indiana
      Bloomington,  Indiana,  United States; Recruiting
      Evansville,  Indiana,  United States; Recruiting
      Indianapolis,  Indiana,  United States; Recruiting
Iowa
      Waterloo,  Iowa,  United States; Recruiting
Kansas
      Arkansas City,  Kansas,  United States; Recruiting
      Kansas City,  Kansas,  United States; Recruiting
      Overland Park,  Kansas,  United States; Recruiting
      Wichita,  Kansas,  United States; Recruiting
Kentucky
      Louisville,  Kentucky,  United States; Recruiting
Maine
      Auburn,  Maine,  United States; Recruiting
Michigan
      Livonia,  Michigan,  United States; Recruiting
Minnesota
      Edina,  Minnesota,  United States; Recruiting
Nebraska
      Omaha,  Nebraska,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Edison,  New Jersey,  United States; Recruiting
      Margate,  New Jersey,  United States; Recruiting
New York
      New Hyde Park,  New York,  United States; Recruiting
      Rochester,  New York,  United States; Recruiting
      Syracuse,  New York,  United States; Recruiting
North Carolina
      Hickory,  North Carolina,  United States; Recruiting
      Raleigh,  North Carolina,  United States; Recruiting
      Statesville,  North Carolina,  United States; Recruiting
      Winston Salem,  North Carolina,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  United States; Recruiting
Oklahoma
      Tulsa,  Oklahoma,  United States; Recruiting
Oregon
      Medford,  Oregon,  United States; Recruiting
      Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Allentown,  Pennsylvania,  United States; Recruiting
      Altoona,  Pennsylvania,  United States; Recruiting
      Downingtown,  Pennsylvania,  United States; Recruiting
      Sellerville,  Pennsylvania,  United States; Recruiting
      Tipton,  Pennsylvania,  United States; Recruiting
Rhode Island
      Warwick,  Rhode Island,  United States; Recruiting
South Carolina
      Charleston,  South Carolina,  United States; Recruiting
      Mt. Pleasant,  South Carolina,  United States; Recruiting
      Simpsonville,  South Carolina,  United States; Recruiting
Tennessee
      Chattanooga,  Tennessee,  United States; Recruiting
      Morristown,  Tennessee,  United States; Recruiting
Texas
      Corpus Christi,  Texas,  United States; Recruiting
      Dallas,  Texas,  United States; Recruiting
      Euless,  Texas,  United States; Recruiting
      San Antonio,  Texas,  United States; Recruiting
      The Colony,  Texas,  United States; Recruiting
Utah
      Ogden,  Utah,  United States; Recruiting
      Salt Lake City,  Utah,  United States; Recruiting
Virginia
      Norfolk,  Virginia,  United States; Recruiting
      Richmond,  Virginia,  United States; Recruiting
Washington
      Renton,  Washington,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  United States; Recruiting

Study ID Numbers:  01-04-TL-475-009
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143676
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06