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Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

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ClinicalTrials.gov Identifier: NCT00688558
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:
Akros Pharma Inc.

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 simvastatin 40 mg in patients with low HDL

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: JTT-705 600 mg and simvastatin 40 mg Drug: Placebo and simvastatin 40 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 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 Simvastatin 40 mg in Patients With Low HDL Levels
Study Start Date : February 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
JTT-705 600 mg and simvastatin 40 mg
Drug: JTT-705 600 mg and simvastatin 40 mg
  • JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
  • Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments
Placebo Comparator: 2
Placebo and simvastatin 40 mg
Drug: Placebo and simvastatin 40 mg
  • Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
  • Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments



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 ]


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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

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): NCT00688558


Locations
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Akros Pharma Inc.

Responsible Party: Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00688558     History of Changes
Other Study ID Numbers: AT705-X-03-003
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
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors