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Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

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ClinicalTrials.gov Identifier: NCT00688896
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 the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.

Condition or disease Intervention/treatment Phase
Type II Hyperlipidemia Drug: JTT-705 600 mg and pravastatin 40 mg Drug: JTT-705 300 mg and pravastatin 40 mg Drug: Placebo and pravastatin 40 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 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 Efficacy and Safety of JTT-705 (300 mg or 600 mg) Versus Placebo in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Study Start Date : June 2002
Actual Primary Completion Date : April 2003
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
JTT-705 600 mg and pravastatin 40 mg
 Drug: JTT-705 600 mg and pravastatin 40 mg
  • JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment
  • Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Experimental: 2
JTT-705 300 mg and pravastatin 40 mg
 Drug: JTT-705 300 mg and pravastatin 40 mg
  • JTT-705 300 mg tablets, 300 mg dose, 1 tablet, oral, once daily, immediately following breakfast and/or assessment
  • Placebo tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments
  • Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime
Placebo Comparator: 3
Placebo and pravastatin 40 mg
 Drug: Placebo and pravastatin 40 mg
  • Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
  • Pravastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, at bedtime


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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having lipid values as indicated below:

    • HDL-C less than 1.6 mmol/L (60 mg/dL)
    • TG less than 4.5 mmol/L (400 mg/dL)
  • LDL more than 4.0 mmol/L (160 mg/dL)
  • Patients with CHD or CHD risk equivalent
  • Male and females between 18 and 65 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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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): NCT00688896


Locations
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Akros Pharma Inc.
More Information
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Responsible Party: Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT00688896     History of Changes
Other Study ID Numbers: AT705-X-02-001
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Pravastatin
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipoproteinemia Type II
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
 Genetic Diseases, Inborn
Dalcetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors