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

This study has been completed.
Sponsor:
Information provided by:
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00688558
First received: May 29, 2008
Last updated: June 2, 2008
Last verified: May 2008

May 29, 2008
June 2, 2008
February 2004
December 2004   (final data collection date for primary outcome measure)
% change from baseline in HDL-C; inhibition of CETP activity [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688558 on ClinicalTrials.gov Archive Site
  • % change from baseline in LDL-C and TC/HDL-C [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of JTT-705 [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
  • 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
  • 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
  • Experimental: 1
    JTT-705 600 mg and simvastatin 40 mg
    Intervention: Drug: JTT-705 600 mg and simvastatin 40 mg
  • Placebo Comparator: 2
    Placebo and simvastatin 40 mg
    Intervention: Drug: Placebo and simvastatin 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
92
March 2006
December 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00688558
AT705-X-03-003
No
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