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OpenTrials
Completed

NCT Number: NCT00686010

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

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.

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Key information

Conditions

Type II Hyperlipidaemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

JTT-705 300mg

Drug

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

JTT-705 600mg

Drug

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

JTT-705 900mg

Drug

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

Primary outcomes

  1. %change from baseline in HDL-C, Inhibition of CETP activity

    Time frame: 4-weeks

Secondary outcomes

  1. %change from baseline in LDL-C and TC/HDL ratio

    Time frame: 4-weeks

Sponsors and collaborators

Lead sponsor

Japan Tobacco Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
May 29, 2008
Registry last updated
May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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