NCT00688558

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

A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Simvastatin 40 mg in Patients With Low HDL Levels

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Dyslipidemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-02-01
• Primary completion: 2004-12-01
• Completion: 2006-03-01
• First posted: 2008-06-03
• Last updated: 2008-06-03

Locations

1 site across 1 country: Netherlands