Status:

COMPLETED

Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia

Lead Sponsor:

Japan Tobacco Inc.

Conditions:

Type II Hyperlipidaemia

Eligibility:

All Genders

22-65 years

Phase:

PHASE2

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2000

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2001

Estimated Enrollment :

198 Patients enrolled

Trial Details

Trial ID

NCT00686010

Start Date

May 1 2000

End Date

June 1 2001

Last Update

May 29 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen

Amsterdam, Netherlands