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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type II Hyperlipidemia

Intervention / Treatment
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* Drug: JTT-705 600 mg and pravastatin 40 mg
* Drug: JTT-705 300 mg and pravastatin 40 mg
* Drug: Placebo and pravastatin 40 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>JTT-705 600 mg and pravastatin 40 mg | Drug: JTT-705 600 mg and pravastatin 40 mg<br>* 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<br>|
| Experimental: 2<br>JTT-705 300 mg and pravastatin 40 mg | Drug: JTT-705 300 mg and pravastatin 40 mg<br>* 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<br>|
| Placebo Comparator: 3<br>Placebo and pravastatin 40 mg | Drug: Placebo and pravastatin 40 mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in HDL-C; inhibition of CETP activity |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in LDL-C and TC/HDL-C |  | 4-weeks | 
| Plasma concentration of JTT-705 |  | 4-weeks |