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Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

NCT ID: NCT00689442

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Dyslipidemia

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 atorvastatin 20 mg

Group Type EXPERIMENTAL

JTT-705 600 mg and atorvastatin 20 mg

Intervention Type DRUG

* 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

2

Placebo and atorvastatin 20 mg

Group Type PLACEBO_COMPARATOR

Placebo and atorvastatin 20 mg

Intervention Type DRUG

* 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

Interventions

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JTT-705 600 mg and atorvastatin 20 mg

* 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

Placebo and atorvastatin 20 mg

* 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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-03-002

Identifier Type: -

Identifier Source: org_study_id