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Effect of TAK-475 or Placebo on Blood Cholesterol Levels in Subjects That Are Co-Administered Atorvastatin - Article


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Cholesterol

 



Clinical Trial: Effect of TAK-475 or Placebo on Blood Cholesterol Levels in Subjects That Are Co-Administered Atorvastatin

This study is currently recruiting patients.
Verified by Takeda Global Research & Development Center, Inc. August 2005

Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00143676

Purpose

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

MedlinePlus related topics:  Cholesterol;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: A Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-475 50 Mg, 100 Mg, or Placebo When Co-Administered with Atorvastatin (10 Mg to 40 Mg) in Subjects with Primary Hypercholesterolemia

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

Study start: August 2005;  Expected completion: October 2007
Last follow-up: October 2006;  Data entry closure: December 2006

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.

Eligibility

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

Location and Contact Information

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

More Information

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

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