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

NCT00688896 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2008-06-03

No results posted yet for this study

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.

Conditions

  • Type II Hyperlipidemia

Interventions

DRUG

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

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

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

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2003-04-30
Completion
2004-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688896 on ClinicalTrials.gov