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

NCT ID: NCT00688896

Last Updated: 2008-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-03-31

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.

Detailed Description

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Conditions

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Type II Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

JTT-705 600 mg and pravastatin 40 mg

Group Type EXPERIMENTAL

JTT-705 600 mg and pravastatin 40 mg

Intervention Type DRUG

* 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

2

JTT-705 300 mg and pravastatin 40 mg

Group Type EXPERIMENTAL

JTT-705 300 mg and pravastatin 40 mg

Intervention Type DRUG

* 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

3

Placebo and pravastatin 40 mg

Group Type PLACEBO_COMPARATOR

Placebo and pravastatin 40 mg

Intervention Type DRUG

* 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

Interventions

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JTT-705 600 mg and pravastatin 40 mg

* 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

Intervention Type DRUG

JTT-705 300 mg and pravastatin 40 mg

* 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

Intervention Type DRUG

Placebo and pravastatin 40 mg

* 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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akros Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Akros Pharma Inc.

Locations

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Amsterdam, Amsterdam, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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AT705-X-02-001

Identifier Type: -

Identifier Source: org_study_id