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OpenTrials
Completed

NCT Number: NCT00697203

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients 18-75 years of age;
  • dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Exclusion criteria

  • women who are pregnant, breastfeeding, or of child-bearing potential;
  • morbid obesity;
  • uncontrolled hypertension;
  • poorly controlled or insulin-treated diabetes;
  • high creatinine levels or history of statin-associated myopathy.

Treatment and study plan

Placebo

Drug

po daily for 12 weeks

Pravastatin

Drug

40mg po daily for 12 weeks

Dalcetrapib

Drug

300mg po daily for 12 weeks

Primary outcomes

  1. Absolute Change From Baseline in HDL-C Level\n

    Time frame: Week 12

  2. Percent Change From Baseline in HDL-C Level\n

    Time frame: 12 Weeks

Secondary outcomes

  1. Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI

    Time frame: 12 weeks

  2. Percent Change of Fasting Glucose Level

    Time frame: 12 weeks

  3. AEs, Lab Parameters, Vital Signs, ECG

    Time frame: Through 9 Months

  4. Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB

    Time frame: Baseline and at 12 Weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 13, 2008
Registry last updated
Jan 2, 2020

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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