NCT00688896

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2002-06-01
• Primary completion: 2003-04-01
• Completion: 2004-03-01
• First posted: 2008-06-03
• Last updated: 2008-06-03

Locations

1 site across 1 country: Netherlands