A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
1 other identifier
interventional
77
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2007
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2006
CompletedFirst Posted
Study publicly available on registry
November 16, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
January 3, 2020
CompletedJanuary 3, 2020
December 1, 2019
1 year
November 15, 2006
July 17, 2019
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in HDL-C
Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
Secondary Outcomes (1)
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)
Baseline and Week 24 (Week 48 from start of NC19453)
Study Arms (2)
dalcetrapib (RO4607381)
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- patients who have completed treatment on study NC19453.
You may not qualify if:
- any significant lymph node abnormalities at the end of study NC19453.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Louisville, Kentucky, 40213, United States
Unknown Facility
Bethesda, Maryland, 20817, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2006
First Posted
November 16, 2006
Study Start
January 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
January 3, 2020
Results First Posted
January 3, 2020
Record last verified: 2019-12