Trial | NCT00688896  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pravastatin ro4402257 ...

  • Study Participants

    155
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.
Study Started
Jun 30
2002
Primary Completion
Apr 30
2003
Study Completion
Mar 31
2004
Last Update
Jun 03
2008
Estimate

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

1 Experimental

JTT-705 600 mg and pravastatin 40 mg

2 Experimental

JTT-705 300 mg and pravastatin 40 mg

3 Placebo Comparator

Placebo and pravastatin 40 mg

Criteria 

Inclusion Criteria:

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 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
No Results Posted