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

Primary Purpose

Type II Hyperlipidemia

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

JTT-705 600 mg and pravastatin 40 mg

JTT-705 300 mg and pravastatin 40 mg

Placebo and pravastatin 40 mg

About this trial

This is an interventional treatment trial for Type II Hyperlipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

JTT-705 600 mg and pravastatin 40 mg

JTT-705 300 mg and pravastatin 40 mg

Placebo and pravastatin 40 mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Plasma concentration of JTT-705

Full Information

NCT ID

NCT00688896

First Posted

May 29, 2008

Last Updated

June 2, 2008

Sponsor

Akros Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00688896

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Akros Pharma Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type II Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

155 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

JTT-705 600 mg and pravastatin 40 mg

Arm Title

Arm Type

Experimental

Arm Description

JTT-705 300 mg and pravastatin 40 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo and pravastatin 40 mg

Intervention Type

Drug

Intervention Name(s)

JTT-705 600 mg and pravastatin 40 mg

Intervention Description

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

Intervention Name(s)

JTT-705 300 mg and pravastatin 40 mg

Intervention Description

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

Intervention Name(s)

Placebo and pravastatin 40 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4-weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4-weeks

Title

Plasma concentration of JTT-705

Time Frame

4-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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