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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib | Experimental | Dalcetrapib 900mg po daily for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo po daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po daily for 24 weeks |
| |
| dalcetrapib |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in HDL-C | Baseline and Week 24 | |
| Percent Change From Baseline in HDL-C | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass | Baseline and Weeks 24 | |
| Change in Mesenteric Lymph Nodes | Baseline and 48 Weeks | |
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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 |
|---|---|---|---|---|---|---|
| Chicago | Illinois | 60610 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib | Dalcetrapib 900mg po daily for 24 weeks dalcetrapib: 900mg po daily for 24 weeks |
| FG001 | Placebo | Placebo po daily for 24 weeks Placebo: po daily for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
900mg po daily for 24 weeks |
|
| Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB) |
| Baseline and 48 Weeks |
| Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity | Baseline and 48 Weeks |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| 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 |
| Berlin | 10707 | Germany |
| Bochum | 06097 | Germany |
| Dortmund | 44137 | Germany |
| Erlangen | 91054 | Germany |
| Freiburg im Breisgau | 79106 | Germany |
| Hamburg | 20249 | Germany |
| München | 80336 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib | Dalcetrapib 900mg po daily for 24 weeks dalcetrapib: 900mg po daily for 24 weeks |
| BG001 | Placebo | Placebo po daily for 24 weeks 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 | Absolute Change From Baseline in HDL-C | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 24 |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Weeks 24 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Mesenteric Lymph Nodes | Posted | Number | Number of Nodes | Baseline and 48 Weeks | Number of Mesenteric Lymph Nodes | Number of Mesenteric Lymph Nodes |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB) | Posted | Least Squares Mean | Standard Error | Percent change in mg/dL | Baseline and 48 Weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity | Posted | Least Squares Mean | Standard Error | percent change in pMOL/mcL/hr | Baseline and 48 Weeks |
|
| |||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in HDL-C | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline and Week 24 |
|
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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 | Dalcetrapib 900mg po daily for 24 weeks dalcetrapib: 900mg po daily for 24 weeks | 11 | 89 | 0 | 89 | ||
| EG001 | Placebo | Placebo po daily for 24 weeks Placebo: po daily for 24 weeks | 6 | 46 | 0 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders |
| |||
| Coronary Artery Disease | Cardiac disorders |
| |||
| Angina Pectoris | Cardiac disorders |
| |||
| Lymphadenopathy | Blood and lymphatic system disorders |
| |||
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Metastatic Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Non-Cardiac Chest Pain | General disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| OsteoArthritis | Musculoskeletal and connective tissue disorders |
| |||
| Cholecystitis Acute | Hepatobiliary disorders |
| |||
| Nerocysterosis | Infections and infestations |
|
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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 |
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| Number of Mesenteric Lymph Nodes |
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