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

Dyslipidemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697203
• Other study ID #: NC18589
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Placebo
po daily for 12 weeks
• Pravastatin
40mg po daily for 12 weeks
• Dalcetrapib
300mg po daily for 12 weeks
• Dalcetrapib
600mg po daily for 12 weeks
• Dalcetrapib
900mg po daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in HDL-C Level\n		Week 12
Primary	Percent Change From Baseline in HDL-C Level\n		12 Weeks
Secondary	Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI		12 weeks
Secondary	Percent Change of Fasting Glucose Level		12 weeks
Secondary	AEs, Lab Parameters, Vital Signs, ECG		Through 9 Months
Secondary	Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB		Baseline and at 12 Weeks