Trial | NCT00686010  Report issue

Title

Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ro4402257 ...

  • Study Participants

    198
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
Study Started
May 31
2000
Primary Completion
Jan 31
2001
Study Completion
Jun 30
2001
Last Update
May 29
2008
Estimate

Drug Placebo

Placebo tablet, 3 tablets, oral, once daily after breakfast

Drug JTT-705 300mg

JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.

Drug JTT-705 600mg

JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast

Drug JTT-705 900mg

JTT-705 tablet, 3 tablets, oral, once daily, after breakfast

1 Placebo Comparator

Placebo

2 Experimental

JTT-705 300mg

3 Experimental

JTT-705 600mg

4 Experimental

JTT-705 900mg

Criteria 

Inclusion Criteria:

Patients with of Type II hyperlipidaemia

Patients having lipid values as indicated below:

HDL-C < 1.6 mmol/l
TG < 4.5 mmol/l
Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

Body Mass Index (BMI) > 35 kg/m²
Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
Concomitant use of medications identified in the protocol
No Results Posted