Effect of TAK-475 With or Without Ezetimibe Versus Ezetimibe Alone in Patients With Primary Dyslipidemia Needing to Reduce Their Low-Density Cholesterol (“Bad” Cholesterol).
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; Hypercholesterolemia
Intervention: TAK-475 (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Edward Piper, MBBS, Study Director, Affiliation: Takeda Europe R&D Centre Ltd
Summary
Patients on the study will keep to a stable diet for a 6 week run-in period. They will then
be given one of three different treatments for 24 weeks: TAK-475 alone, TAK-475 plus
ezetimibe, or ezetimibe alone. Blood tests will be carried out 3 or 4 times during run-in
and 8 times during treatment.
Clinical Details
Official title: A Double-Blind, Double Dummy, Randomized, Parallel Group, Multi-Center, Phase III Study to Evaluate the Efficacy and Safety of TAK-475 Alone and TAK-475 Administered in Combination With Ezetimibe Versus Ezetimibe Alone in Subjects With Primary Dyslipidemia.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: change in LDL-C at 24 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject is a male or female at least 18 years of age.
- The subject has a documented history of dyslipidemia.
- The subject has been stable for at least 4 weeks on a standardized lipid lowering diet
and is willing and able to comply with the diet for the duration of the study.
- The subject is in good physical and mental health as determined by a physician.
Exclusion Criteria:
- The subject has elevated ALT, AST, CPK, or serum creatinine above the pre-specified
criteria.
- The subject has diabetes mellitus type 1 or 2
- The subject has a presence or history of positive HIV or hepatitis B or C status
- The subject has taken any excluded medication (eg, other lipid lowering agents) in the
30 days before screening or is planning to take any such medication during the study.
Locations and Contacts
Tallinn, Estonia
Tartu, Estonia
Riga, Latvia
Smolensk, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
Tyumen, Russian Federation
Moscow, Russian Federation
Kragujevac, Serbia and Montenegro
Additional Information
Starting date: October 2005
Ending date: June 2007
Last updated: September 8, 2006
|
