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Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

NCT ID: NCT00686010

Last Updated: 2008-05-29

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

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2001-06-30

Brief Summary

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To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.

Detailed Description

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Conditions

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Type II Hyperlipidaemia

Keywords

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CETP Inhibitor HDL-C LDL-C Apolipoprotein

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet, 3 tablets, oral, once daily after breakfast

2

JTT-705 300mg

Group Type EXPERIMENTAL

JTT-705 300mg

Intervention Type DRUG

JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.

3

JTT-705 600mg

Group Type EXPERIMENTAL

JTT-705 600mg

Intervention Type DRUG

JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast

4

JTT-705 900mg

Group Type EXPERIMENTAL

JTT-705 900mg

Intervention Type DRUG

JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

Interventions

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Placebo

Placebo tablet, 3 tablets, oral, once daily after breakfast

Intervention Type DRUG

JTT-705 300mg

JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.

Intervention Type DRUG

JTT-705 600mg

JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast

Intervention Type DRUG

JTT-705 900mg

JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with of Type II hyperlipidaemia
* Patients having lipid values as indicated below:

* HDL-C \< 1.6 mmol/l
* TG \< 4.5 mmol/l
* Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria

* Body Mass Index (BMI) \> 35 kg/m²
* Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
* Concomitant use of medications identified in the protocol
Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Tobacco Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Japan Tobacco Inc.

Locations

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Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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CAY2-1

Identifier Type: -

Identifier Source: org_study_id