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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dalcetrapib (RO4607381) | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalcetrapib (RO4607381) | Drug | 900mg po daily for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in HDL-C | Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522)) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | 46260 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib (RO4607381) | dalcetrapib (RO4607381): 900mg po daily for 24 weeks |
| FG001 | Placebo | placebo: po daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
po daily for 24 weeks |
|
| Iowa City |
| Iowa |
| 52242 |
| United States |
| Louisville | Kentucky | 40213 | United States |
| Bethesda | Maryland | 20817 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Salt Lake City | Utah | 84132 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib (RO4607381) | dalcetrapib (RO4607381): 900mg po daily for 24 weeks |
| BG001 | Placebo | placebo: po daily for 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in HDL-C | Posted | Least Squares Mean | Standard Error | Percentage Change of HDL-C | Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522)) |
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| ||||||||||||||||||||||||||||||
| Secondary | 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) | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 24 (Week 48 from start of NC19453) |
|
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Study was an extension of NC19453. Adverse Event data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dalcetrapib (RO4607381) | dalcetrapib (RO4607381): 900mg po daily for 24 weeks | 0 | 0 | 0 | 0 | ||
| EG001 | Placebo | placebo: po daily for 24 weeks | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Black | DalCor Pharmaceuticals | rblack@dalcorpharma.com |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C411602 | dalcetrapib |
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| Male |
|
|