Clinical trial NCT00353522: A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Official title: A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-07-18
Enrollment: 135
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 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-75 years of age;
* CHD or CHD risk equivalent;
* body weight \<125kg at visit 1.

Exclusion Criteria:

* recent (within 3 weeks of screening) clinically significant coronary events;
* history of statin-associated myopathy, or intolerance to statin;
* history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
* exposure to RO4607381 in past 12 months.

Primary outcomes:
measure: Absolute Change From Baseline in HDL-C
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in HDL-C
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass
timeFrame: Baseline and Weeks 24
measure: Change in Mesenteric Lymph Nodes
timeFrame: Baseline and 48 Weeks
measure: Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
timeFrame: Baseline and 48 Weeks
measure: Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity
timeFrame: Baseline and 48 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Minneapolis
country: United States
state: Minnesota
city: Statesville
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Salt Lake City
country: United States
state: Utah
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Dortmund
country: Germany
city: Erlangen
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: München
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: