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

Akros Pharma Inc.155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

155

Conditions

Type II Hyperlipidemia

Interventions

JTT-705 600 mg and pravastatin 40 mgDRUG

* 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

JTT-705 300 mg and pravastatin 40 mgDRUG

* 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

Placebo and pravastatin 40 mgDRUG

* 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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Amsterdam, Amsterdam, Netherlands

Outcomes

Primary Outcomes

% change from baseline in HDL-C; inhibition of CETP activity

Time frame: 4-weeks

Secondary Outcomes

% change from baseline in LDL-C and TC/HDL-C

Time frame: 4-weeks

Plasma concentration of JTT-705

Time frame: 4-weeks

Data from ClinicalTrials.gov

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