Clinical trial NCT00697203: A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change From Baseline in HDL-C Level\n
timeFrame: Week 12
measure: Percent Change From Baseline in HDL-C Level\n
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
timeFrame: 12 weeks
measure: Percent Change of Fasting Glucose Level
timeFrame: 12 weeks
measure: AEs, Lab Parameters, Vital Signs, ECG
timeFrame: Through 9 Months
measure: Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
timeFrame: Baseline and at 12 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Newark
country: United States
state: Delaware
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Chalmette
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Scarborough
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Concord
country: United States
state: New Hampshire
city: Charlotte
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Springdale
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Warminster
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: