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Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

NCT00688558 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2008-06-03

No results posted yet for this study

Summary

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 simvastatin 40 mg in patients with low HDL

Conditions

Interventions

DRUG

JTT-705 600 mg and simvastatin 40 mg

* JTT-705 300 mg tablets, 600 mg dose, 2 tablets, oral, once daily, immediately following breakfast and/or assessment * Simvastatin 40 mg tablets, 40 mg dose, one tablet, oral, once daily, immediately following breakfast and/or assessments

DRUG

Placebo and simvastatin 40 mg

* Placebo tablets, 2 tablets, oral, once daily, immediately following breakfast and/or assessments * Simvastatin 40 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2004-12-31
Completion
2006-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT00688558 on ClinicalTrials.gov