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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00268697 |
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 |
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Hyperlipidemia Hypercholesterolemia |
Drug: TAK-475 |
Phase III |
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. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Edward Piper, MBBS | Takeda Europe R&D Centre Ltd |
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 |
Hyperlipidemia Hypercholesterolemia |
Metabolic Diseases Hyperlipidemias Ezetimibe Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antilipemic Agents Anticholesteremic Agents Pharmacologic Actions |