Status:
COMPLETED
Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia
Lead Sponsor:
Akros Pharma Inc.
Conditions:
Type II Hyperlipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 documen...
Eligibility Criteria
Inclusion
- Patients having lipid values as indicated below:
- HDL-C less than 1.6 mmol/L (60 mg/dL)
- TG less than 4.5 mmol/L (400 mg/dL)
- LDL more than 4.0 mmol/L (160 mg/dL)
- Patients with CHD or CHD risk equivalent
- Male and females between 18 and 65 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 :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00688896
Start Date
June 1 2002
End Date
March 1 2004
Last Update
June 3 2008
Active Locations (1)
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1
Amsterdam, Amsterdam, Netherlands