Trial information
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Status: No longer recruiting
Protocol number: NC20716
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
Brief summary: This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a CHD risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 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 (Week 48 from start of NC19453)
2. Potential changes in mesenteric lymph nodes Time frame: Throughout study
Key secondary outcomes: 1. Change from baseline in HDL-C, TC, LDL-C, TG, ApoB and ApoAl Time frame: Week 24 (Week 48 from start of NC19453)
2. AEs, laboratory parameters, vital signs Time frame: Throughout study
Inclusion criteria:
- patients who have completed treatment on study NC19453.
Exclusion criteria:
- any significant lymph node abnormalities at the end of study NC19453.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 11/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Chicago, IL
- Indianapolis , IN
- Iowa City, IA
- Louisville, KY
- Bethesda, MD
- Minneapolis, MN
- Statesville, NC
- Cincinnati, OH
- Salt Lake City, UT
