Back to resultsA Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dalcetrapib (RO4607381)
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- patients who have completed treatment on study NC19453.
Exclusion Criteria:
- any significant lymph node abnormalities at the end of study NC19453.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dalcetrapib (RO4607381)
placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent Change From Baseline in HDL-C
Secondary Outcome Measures
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00400439
Brief Title
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Official Title
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dalcetrapib (RO4607381)
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
dalcetrapib (RO4607381)
Intervention Description
900mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
po daily for 24 weeks
Primary Outcome Measure Information:
Title
Percent Change From Baseline in HDL-C
Time Frame
Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
Secondary Outcome Measure Information:
Title
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Time Frame
Baseline and Week 24 (Week 48 from start of NC19453)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who have completed treatment on study NC19453.
Exclusion Criteria:
any significant lymph node abnormalities at the end of study NC19453.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
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A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
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