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Sponsored by: |
Akros Pharma Inc. |
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Information provided by: | Akros Pharma Inc. |
ClinicalTrials.gov Identifier: | NCT00689442 |
The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL
Condition | Intervention | Phase |
---|---|---|
Dyslipidemia |
Drug: JTT-705 600 mg and atorvastatin 20 mg Drug: Placebo and atorvastatin 20 mg |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels |
Enrollment: | 105 |
Study Start Date: | January 2004 |
Study Completion Date: | March 2006 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
JTT-705 600 mg and atorvastatin 20 mg
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Drug: JTT-705 600 mg and atorvastatin 20 mg
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2: Placebo Comparator
Placebo and atorvastatin 20 mg
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Drug: Placebo and atorvastatin 20 mg
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients having lipid values as indicated below:
Exclusion Criteria:
Responsible Party: | Akros Pharma Inc. ( Shoji Hoshino, DVM, Vice President, Clinical Development ) |
Study ID Numbers: | AT705-X-03-002 |
Study First Received: | May 29, 2008 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00689442 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Metabolic Diseases Metabolic disorder Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |