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This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 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 | 600mg po daily for 24 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Wall Thickness | 24 months | |
| Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance | 6 months | |
| Change From Baseline in Vessel MR Determined Plaque Anatomy | Up to 24 months | |
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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 |
|---|---|---|---|---|---|---|
| Jacksonville | Florida | 32216 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24135322 | Derived | Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009. | |
| 23942908 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib (RO4607381) | Dalcetrapib (RO4607381): 600mg po daily for 24 months |
| FG001 | Placebo | Placebo: po daily for 24 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
po daily for 24 months |
|
| Blood Lipids,Lipoproteins |
| Throughout study |
| Biomarkers | Up to 24 months |
| CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure | Throughout study |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Minneapolis | Minnesota | 55455 | United States |
| Kansas City | Missouri | 64111 | United States |
| New York | New York | 10029 | United States |
| Statesville | North Carolina | 28677 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cleveland | Ohio | 44195 | United States |
| Houston | Texas | 77030 | United States |
| Seattle | Washington | 98108 | United States |
| Montreal | Quebec | H1T 1C8 | Canada |
| Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, Millon A, Rosenbaum D, Tawakol A, Woodward M, Bucerius J, Moshier E, Godbold J, Kallend D, Farkouh ME, Fuster V, Rudd JH, Fayad ZA. The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1884-93. doi: 10.1007/s00259-013-2518-4. Epub 2013 Aug 14. |
| 21908036 | Derived | Fayad ZA, Mani V, Woodward M, Kallend D, Abt M, Burgess T, Fuster V, Ballantyne CM, Stein EA, Tardif JC, Rudd JH, Farkouh ME, Tawakol A; dal-PLAQUE Investigators. Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet. 2011 Oct 29;378(9802):1547-59. doi: 10.1016/S0140-6736(11)61383-4. Epub 2011 Sep 9. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib (RO4607381) | Dalcetrapib (RO4607381): 600mg po daily for 24 months |
| BG001 | Placebo | Placebo: po daily for 24 months |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | 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 Mean Wall Thickness | Posted | Least Squares Mean | Standard Error | Percent Change | 24 months |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel. | Posted | Least Squares Mean | Standard Error | Ratio | 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance | Data not collected | Posted | 6 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vessel MR Determined Plaque Anatomy | Data not collected | Posted | Up to 24 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Blood Lipids,Lipoproteins | Data not collected | Posted | Throughout study |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Biomarkers | Data not collected | Posted | Up to 24 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure | Data not collected | Posted | Throughout study |
|
|
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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): 600mg po daily for 24 months | 20 | 64 | 0 | 64 | ||
| EG001 | Placebo | Placebo: po daily for 24 months | 19 | 66 | 0 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders |
| |||
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Bronchitis | Infections and infestations |
| |||
| Scrotal Abcess | Infections and infestations |
| |||
| Scrotal Infection | Infections and infestations |
| |||
| Non-Cardiac Chest Pain | General disorders |
| |||
| Chest Pain | General disorders |
| |||
| Stent-Graft Endoleak | General disorders |
| |||
| Cardiac Failure Congestive | Cardiac disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
| |||
| Atrial Flutter | Cardiac disorders |
| |||
| Bradycardia | Cardiac disorders |
| |||
| Tachycardia | Cardiac disorders |
| |||
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Small Cell Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Squamous Cell Carcinoma of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Gastritis Erosive | Gastrointestinal disorders |
| |||
| Gastrointestinal Hemorrhage | Gastrointestinal disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Transient Ischemic Attack | Nervous system disorders |
| |||
| Joint Dislocation | Injury, poisoning and procedural complications |
| |||
| Radius Fracture | Injury, poisoning and procedural complications |
| |||
| Diabetic Ketoacidosis | Metabolism and nutrition disorders |
| |||
| Renal Failure Acute | Renal and urinary disorders |
| |||
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Ischaemia | Vascular disorders |
|
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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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| United States |
|
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