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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003406-10 |
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This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po daily for 36 weeks |
| |
| dalcetrapib |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in % Flow Mediated Dilatation (FMD) | Baseline and 12 weeks | |
| Change From Baseline in Mean BP, Measured by BP Monitoring | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in % FMD | baseline and 36 weeks | |
| Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | Baseline to 36 weeks | |
| CETP Activity |
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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 |
|---|---|---|---|---|---|---|
| Feldkirch | 6800 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22345126 | Derived | Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16. | |
| 21128879 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib | dalcetrapib: 600mg po daily for 36 weeks |
| FG001 | Placebo | Placebo: po daily for 36 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
600mg po daily for 36 weeks |
|
| Up to 36 weeks |
| Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9 | Baseline and 36 weeks |
| Change From Baseline in Mean BP, Measured by BP Monitoring | Up to 36 weeks |
| Percent Change CETP Mass | baseline to 36 weeks |
| Paris |
| 75908 |
| France |
| Bonn | 53127 | Germany |
| Dortmund | 44137 | Germany |
| Frankfurt | 60596 | Germany |
| Mainz | 55131 | Germany |
| Wuppertal | 42117 | Germany |
| Pisa | Tuscany | 56100 | Italy |
| Amsterdam | 1105 AZ | Netherlands |
| Breda | 4811 SW | Netherlands |
| Eindhoven | 5611 NJ | Netherlands |
| Goes | 4462 RA | Netherlands |
| Groningen | 9711 SG | Netherlands |
| Hoorn | 1625 HV | Netherlands |
| Leiderdorp | 2352 RA | Netherlands |
| Nijmegen | 6525 EC | Netherlands |
| Rotterdam | 3021 HC | Netherlands |
| Utrecht | 3508 GA | Netherlands |
| Velp | 6883 ES | Netherlands |
| Zoetermeer | 2724 EK | Netherlands |
| Lugano | 6900 | Switzerland |
| Zurich | 8091 | Switzerland |
| Cardiff | CF14 4XN | United Kingdom |
| Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Munzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Luscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib | dalcetrapib: 600mg po daily for 36 weeks |
| BG001 | Placebo | Placebo: po daily for 36 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 | Change From Baseline in % Flow Mediated Dilatation (FMD) | 10 subjects dropped before week 12 | Posted | Least Squares Mean | Standard Error | %FMD | Baseline and 12 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in Mean BP, Measured by BP Monitoring | not all participants were tested | Posted | Mean | Standard Error | mmHg | Baseline and 4 weeks |
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| Secondary | Change From Baseline in % FMD | not all participants were tested | Posted | Least Squares Mean | Standard Deviation | %FMD | baseline and 36 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB | not all participants were tested | Posted | Least Squares Mean | Standard Error | Percent change in mg/dL | Baseline to 36 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | CETP Activity | not all participants were tested | Posted | Least Squares Mean | Standard Error | Percent change pMOL/uL/hr | Up to 36 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9 | not all participants were tested | Posted | Mean | Standard Error | Percent change in ng/mL | Baseline and 36 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean BP, Measured by BP Monitoring | not all participants were tested | Posted | Mean | Standard Error | mmHg | Up to 36 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change CETP Mass | not all participants were tested | Posted | Least Squares Mean | Standard Error | Percent change in ug/mL | baseline to 36 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 | dalcetrapib: 600mg po daily for 36 weeks | 0 | 236 | 12 | 236 | 92 | 236 |
| EG001 | Placebo | Placebo: po daily for 36 weeks | 1 | 236 | 14 | 236 | 112 | 236 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders |
| |||
| Angina Unstable | Cardiac disorders |
| |||
| Atrial Fibrilation | Cardiac disorders |
| |||
| Cardiac Failure Congestive | Cardiac disorders |
| |||
| Appendicitis | Infections and infestations |
| |||
| Appendicitis Perforated | Infections and infestations |
| |||
| Bronchitis | Infections and infestations |
| |||
| Orchitis | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Viral Infection | Infections and infestations |
| |||
| Gastrointestinal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Dizziness | Nervous system disorders |
| |||
| Migrane | Nervous system disorders |
| |||
| Transient Ischemic Attack | Nervous system disorders |
| |||
| Pain | General disorders |
| |||
| Purexia | General disorders |
| |||
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Urethral Stenosis | Renal and urinary disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Gastric Disorder | Gastrointestinal disorders |
| |||
| Postoperative Thoracic Procedure Complication | Injury, poisoning and procedural complications |
| |||
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders |
| |||
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system 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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