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).

This study is ongoing, but not recruiting participants.

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00268697

Purpose

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.

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

change in LDL-C at 24 weeks

Estimated Enrollment:	1035
Study Start Date:	October 2005
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268697

Locations

Estonia

Tallinn, Estonia

Tartu, Estonia
Latvia

Riga, Latvia
Russian Federation

Smolensk, Russian Federation

Saratov, Russian Federation

St. Petersburg, Russian Federation

Tyumen, Russian Federation

Moscow, Russian Federation
Serbia and Montenegro

Kragujevac, Serbia and Montenegro

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Edward Piper, MBBS

Takeda Europe R&D Centre Ltd

More Information

Study ID Numbers:	TAK-475/EC303
Study First Received:	December 20, 2005
Last Updated:	September 8, 2006
ClinicalTrials.gov Identifier:	NCT00268697
Health Authority:	Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Takeda Global Research & Development Center, Inc.:

Hyperlipidemia
Hypercholesterolemia

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Ezetimibe
Metabolic disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Antilipemic Agents
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009