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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688896
First Posted: June 3, 2008
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Akros Pharma Inc.
May 29, 2008
June 3, 2008
June 3, 2008
June 2002
April 2003   (Final data collection date for primary outcome measure)
% change from baseline in HDL-C; inhibition of CETP activity [ Time Frame: 4-weeks ]
Same as current
No Changes Posted
  • % change from baseline in LDL-C and TC/HDL-C [ Time Frame: 4-weeks ]
  • Plasma concentration of JTT-705 [ Time Frame: 4-weeks ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type II Hyperlipidemia
  • 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
  • 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
  • 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
  • Experimental: 1
    JTT-705 600 mg and pravastatin 40 mg
    Intervention: Drug: JTT-705 600 mg and pravastatin 40 mg
  • Experimental: 2
    JTT-705 300 mg and pravastatin 40 mg
    Intervention: Drug: JTT-705 300 mg and pravastatin 40 mg
  • Placebo Comparator: 3
    Placebo and pravastatin 40 mg
    Intervention: Drug: Placebo and pravastatin 40 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
March 2004
April 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00688896
AT705-X-02-001
No
Not Provided
Not Provided
Shoji Hoshino, DVM, Vice President, Clinical Development, Akros Pharma Inc.
Akros Pharma Inc.
Not Provided
Not Provided
Akros Pharma Inc.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP