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This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for 12 weeks.The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib 300mg | Experimental |
| |
| Dalcetrapib 600mg | Experimental |
| |
| Dalcetrapib 900mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po daily for 12 weeks |
| |
| Pravastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in HDL-C Level\n | Week 12 | |
| Percent Change From Baseline in HDL-C Level\n | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI | 12 weeks | |
| Percent Change of Fasting Glucose Level | 12 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 |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib 300mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 300mg po daily for 12 weeks |
| FG001 | Dalcetrapib 600mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 600mg po daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
40mg po daily for 12 weeks |
|
| Dalcetrapib | Drug | 300mg po daily for 12 weeks |
|
| Dalcetrapib | Drug | 600mg po daily for 12 weeks |
|
| Dalcetrapib | Drug | 900mg po daily for 12 weeks |
|
| AEs, Lab Parameters, Vital Signs, ECG |
| Through 9 Months |
| Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB | Baseline and at 12 Weeks |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Newark | Delaware | 19713 | United States |
| Miami | Florida | 33137 | United States |
| Chicago | Illinois | 60610-4319 | United States |
| Evansville | Indiana | 47714 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Iowa City | Iowa | 52242 | United States |
| Overland Park | Kansas | 66215 | United States |
| Wichita | Kansas | 67207 | United States |
| Louisville | Kentucky | 40213 | United States |
| Chalmette | Louisiana | 70043 | United States |
| Slidell | Louisiana | 70458 | United States |
| Auburn | Maine | 04210 | United States |
| Scarborough | Maine | 04074 | United States |
| Baltimore | Maryland | 21201 | United States |
| Bethesda | Maryland | 20817 | United States |
| Towson | Maryland | 21204 | United States |
| St Louis | Missouri | 63110 | United States |
| Concord | New Hampshire | 03301 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Statesville | North Carolina | 28677 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Springdale | Ohio | 45246 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Warminster | Pennsylvania | 18974 | United States |
| Fort Worth | Texas | 76107 | United States |
| Houston | Texas | 77030 | United States |
| Richmond | Virginia | 23294 | United States |
| Seattle | Washington | 98104 | United States |
| Madison | Wisconsin | 53719 | United States |
| FG002 | Dalcetrapib 900mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 900mg po daily for 12 weeks |
| FG003 | Placebo | Placebo: po daily for 12 weeks Pravastatin: 40mg po daily for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib 300mg | Pravastatin: 40mg po daily for 12 weeks dalcetrapib: 300mg po daily for 12 weeks |
| BG001 | Dalcetrapib 600mg | Pravastatin: 40mg po daily for 12 weeks dalcetrapib: 600mg po daily for 12 weeks |
| BG002 | Dalcetrapib 900mg | Pravastatin: 40mg po daily for 12 weeks dalcetrapib: 900mg po daily for 12 weeks |
| BG003 | Placebo | Placebo: po daily for 12 weeks Pravastatin: 40mg po daily for 12 weeks |
| BG004 | 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 Level\n | Posted | Least Squares Mean | Standard Error | mg/dL | Week 12 |
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| Primary | Percent Change From Baseline in HDL-C Level\n | Posted | Least Squares Mean | Standard Error | Percent change in mg/dL | 12 Weeks |
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| Secondary | Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI | Posted | Least Squares Mean | Standard Error | Percent change in mg/dL | 12 weeks |
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| Secondary | Percent Change of Fasting Glucose Level | Posted | Least Squares Mean | Standard Error | Percent change in mg/dL | 12 weeks |
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| Secondary | AEs, Lab Parameters, Vital Signs, ECG | Data not collected | Posted | Through 9 Months |
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| Secondary | Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB | Posted | Least Squares Mean | Standard Error | Percent Change in Ratio | Baseline and at 12 Weeks |
|
|
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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 300mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 300mg po daily for 12 weeks | 2 | 76 | 0 | 76 | ||
| EG001 | Dalcetrapib 600mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 600mg po daily for 12 weeks | 2 | 68 | 0 | 68 | ||
| EG002 | Dalcetrapib 900mg | Pravastatin: 40mg po daily for 12 weeks Dalcetrapib: 900mg po daily for 12 weeks | 3 | 74 | 0 | 74 | ||
| EG003 | Placebo | Placebo: po daily for 12 weeks Pravastatin: 40mg po daily for 12 weeks | 2 | 74 | 0 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Gastroesophageal Reflux Disease | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Muscle Tightness | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Neuropathy Peripheral | Nervous system disorders |
| |||
| Malaise | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Black | DalCor Pharmaceuticals | rblack@dalcorpharma.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017035 | Pravastatin |
| C411602 | dalcetrapib |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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