Back to resultsSafety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
JTT-705 600 mg and atorvastatin 20 mg
Placebo and atorvastatin 20 mg
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
JTT-705 600 mg and atorvastatin 20 mg
Placebo and atorvastatin 20 mg
Outcomes
Primary Outcome Measures
% change from baseline in HDL-C; inhibition of CETP activity
Secondary Outcome Measures
% change from baseline in LDL-C and TC/HDL-C
Plasma concentration of JTT-705
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00689442
Brief Title
Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
JTT-705 600 mg and atorvastatin 20 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo and atorvastatin 20 mg
Intervention Type
Drug
Intervention Name(s)
JTT-705 600 mg and atorvastatin 20 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo and atorvastatin 20 mg
Intervention Description
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
Primary Outcome Measure Information:
Title
% change from baseline in HDL-C; inhibition of CETP activity
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
% change from baseline in LDL-C and TC/HDL-C
Time Frame
4-weeks
Title
Plasma concentration of JTT-705
Time Frame
4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Amsterdam
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
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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