Status:
COMPLETED
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00688558
Start Date
February 1 2004
End Date
March 1 2006
Last Update
June 3 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam, Amsterdam, Netherlands