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OpenTrials
Completed

NCT Number: NCT00688896

Efficacy and Safety Study of JTT-705 in Combination With Pravastatin 40 mg in Patients With Type II Hyperlipidemia

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.

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Key information

Conditions

Type II Hyperlipidemia 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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

JTT-705 600 mg and pravastatin 40 mg

Drug
  • 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

JTT-705 300 mg and pravastatin 40 mg

Drug
  • 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

Placebo and pravastatin 40 mg

Drug
  • 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

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-C

    Time frame: 4-weeks

  2. Plasma concentration of JTT-705

    Time frame: 4-weeks

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Jun 3, 2008
Registry last updated
Jun 3, 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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