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Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

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ClinicalTrials.gov Identifier: NCT00689442
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
Akros Pharma Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dyslipidemia Drug: JTT-705 600 mg and atorvastatin 20 mg Drug: Placebo and atorvastatin 20 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : March 2006

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
JTT-705 600 mg and atorvastatin 20 mg
 Drug: JTT-705 600 mg and atorvastatin 20 mg
  • JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment
  • Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments
Placebo Comparator: 2
Placebo and atorvastatin 20 mg
 Drug: Placebo and atorvastatin 20 mg
  • Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
  • Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments


Outcome Measures
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Primary Outcome Measures :
  1. % change from baseline in HDL-C; inhibition of CETP activity [ Time Frame: 4-weeks ]

Secondary Outcome Measures :
  1. % change from baseline in LDL-C and TC/HDL-C [ Time Frame: 4-weeks ]
  2. Plasma concentration of JTT-705 [ Time Frame: 4-weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having lipid values as indicated below:

    • HDL-C ≤ 1.0 mmol/L (40 mg/dL)
    • TG ≤4.5 mmol/L (400 mg/dL)
  • Patients with CHD or CHD risk equivalent
  • Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

  • Body Mass Index of ≥ 35 kg/m2
  • Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
  • Concomitant use of medications identified in the protocol
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689442


Locations
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Akros Pharma Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00689442     History of Changes
Other Study ID Numbers: AT705-X-03-002
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Dalcetrapib
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors