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

Dyslipidemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689442
• Other study ID #: AT705-X-03-002
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2008
• Last updated: June 2, 2008
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2008
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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 atorvastatin 20 mg in patients with low HDL

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2006
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• JTT-705 600 mg and atorvastatin 20 mg
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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% change from baseline in HDL-C; inhibition of CETP activity		4-weeks	No
Secondary	% change from baseline in LDL-C and TC/HDL-C		4-weeks	No
Secondary	Plasma concentration of JTT-705		4-weeks	No