Trial information
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Status: No longer recruiting
Protocol number: NC19453
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
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. Target sample size is 105.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study
Condition: Coronary Heart Disease
Intervention type: Drug
Intervention name: RO4607381
Primary outcome: 1. Percentage and absolute change from baseline in HDL-C Time frame: Week 24
Key secondary outcomes: 1. Change from baseline in TC, TG, HDL-C, LDL-C, CETP mass and activity, ApoAl, ApoB Time frame: Weeks 24
2. AEs, laboratory parameters, change in mesenteric lymph nodes Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2006
Trial registration date: 07/19/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Germany
- Berlin
- Bochum
- Dortmund
- Erlangen
- Freiburg
- Hamburg
- München
United States
- Chicago, IL
- Indianapolis , IN
- Iowa City, IA
- Louisville, KY
- Bethesda, MD
- Minneapolis, MN
- Statesville, NC
- Cincinnati, OH
- Salt Lake City, UT
