Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Phase 2
Completed
- Conditions
- Type II Hyperlipidemia
- Interventions
- Drug: JTT-705 600 mg and pravastatin 40 mgDrug: JTT-705 300 mg and pravastatin 40 mgDrug: Placebo and pravastatin 40 mg
- Registration Number
- NCT00688896
- Lead Sponsor
- Akros Pharma Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 155
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 JTT-705 600 mg and pravastatin 40 mg JTT-705 600 mg and pravastatin 40 mg 2 JTT-705 300 mg and pravastatin 40 mg JTT-705 300 mg and pravastatin 40 mg 3 Placebo and pravastatin 40 mg Placebo and pravastatin 40 mg
- Primary Outcome Measures
Name Time Method % change from baseline in HDL-C; inhibition of CETP activity 4-weeks
- Secondary Outcome Measures
Name Time Method % change from baseline in LDL-C and TC/HDL-C 4-weeks Plasma concentration of JTT-705 4-weeks