Skip to main content
OpenTrials
Completed

NCT Number: NCT00689442

Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

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 atorvastatin 20 mg in patients with low HDL

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients having lipid values as indicated below:
  • HDL-C ≤ 1.0 mmol/L (40 mg/dL)
  • TG ≤4.5 mmol/L (400 mg/dL)
  • Patients with CHD or CHD risk equivalent
  • Male and females between 18 and 70 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

Treatment and study plan

JTT-705 600 mg and atorvastatin 20 mg

Drug
  • JTT-705 300 mg tablets, 600 mg dose, oral, once daily, immediately following breakfast and/or assessment
  • Atorvastatin 20 mg tablets, 20 mg dose, oral, once daily, immediately following breakfast and/or assessments

Placebo and atorvastatin 20 mg

Drug
  • Placebo tablet, 2 tablets, oral, once daily, immediately following breakfast and/or assessments
  • Atorvastatin 20 mg tablets, one tablet, oral, once daily, immediately following breakfast and/or assessments

Primary outcomes

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

    Time frame: 4-weeks

Secondary outcomes

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

    Time frame: 4-weeks

  2. Plasma concentration of JTT-705

    Time frame: 4-weeks

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

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 Atorvastatin 20 mg in Patients With Low HDL Levels

Important dates

Study start
2004
Primary completion
2004
Study completion
2006
First posted
Jun 3, 2008
Registry last updated
Jun 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.