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This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalcetrapib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalcetrapib | Drug | Oral doses of 600 mg once daily for 20 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971 | 4 weeks | |
| Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment |
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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 |
|---|---|---|---|---|---|---|
| Pensacola | Florida | 32501 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalcetrapib | dalcetrapib: Oral doses of 600 mg once daily for 20 weeks |
| FG001 | Placebo | placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks |
|
| 20 weeks |
| Percent Change From Baseline in Blood Lipid Levels | 20 weeks |
| Percent Change From Baseline in Lipoprotein Levels | 20 weeks |
| Percent Change From Baseline in Apolipoprotein Levels | 20 weeks |
| Safety: Incidence of Adverse Events | 24 weeks |
| Pensacola |
| Florida |
| 32504 |
| United States |
| Saginaw | Michigan | 48602 | United States |
| Saint Cloud | Minnesota | 56303 | United States |
| Syracuse | New York | 13210 | United States |
| Rapid City | South Dakota | 57701 | United States |
| Chrudim | 537 25 | Czechia |
| České Budějovice | 370 87 | Czechia |
| Hradec Králové | 500 05 | Czechia |
| Jihlava | 586 01 | Czechia |
| Jindřichův Hradec | 377 38 | Czechia |
| Prague | 100 34 | Czechia |
| Semily | 513 31 | Czechia |
| Teplice | 415 01 | Czechia |
| ZlÃn | 762 75 | Czechia |
| Znojmo | 669 02 | Czechia |
| Amsterdam | 1091 AC | Netherlands |
| Arnhem | 6815 AD | Netherlands |
| Beverwijk | 1942 LE | Netherlands |
| Breda | 4818 CK | Netherlands |
| Den Helder | 1782GZ | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Gouda | 2803 HH | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| Nieuwegein | 3435 CM | Netherlands |
| Nijmegen | 6532 SZ | Netherlands |
| Rotterdam | 3045 PM | Netherlands |
| Sneek | 8601 ZK | Netherlands |
| Edinburgh | EH16 4SA | United Kingdom |
| Glasgow | G31 2ER | United Kingdom |
| London | EC1M 6BQ | United Kingdom |
| Stoke-on-Trent | ST4 6QG | United Kingdom |
| Swansea | SA6 6NL | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
2 Pt. had no intake of study medication and were excluded from ITT
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| ID | Title | Description |
|---|---|---|
| BG000 | Dalcetrapib | dalcetrapib: Oral doses of 600 mg once daily for 20 weeks |
| BG001 | Placebo | placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 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 |
| ||||||||||||||||
| 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 High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment | Posted | Least Squares Mean | Standard Error | Percentage raise in HDL-C Levels | 4 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971 | Not Posted | 4 weeks | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment | Not Posted | 20 weeks | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Blood Lipid Levels | Not Posted | 20 weeks | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lipoprotein Levels | Not Posted | 20 weeks | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apolipoprotein Levels | Not Posted | 20 weeks | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Safety: Incidence of Adverse Events | Not Posted | 24 weeks | Participants |
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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: Oral doses of 600 mg once daily for 20 weeks | 10 | 148 | 7 | 148 | ||
| EG001 | Placebo | placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks | 13 | 150 | 8 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
| |||
| Supraventricular Tachicardia | Cardiac disorders |
| |||
| Ventricular Tachicardia | Cardiac disorders |
| |||
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Extranodal Marginal Zone B-Cell Lymphoma (Malt Type) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Rectosigmoid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Gastric Haemorrhage | Gastrointestinal disorders |
| |||
| Gastrointestinal Haemorhage | Gastrointestinal disorders |
| |||
| Rectal Haemorrhage | Gastrointestinal disorders |
| |||
| Liver Abscess | Infections and infestations |
| |||
| Mycobacterial Infection | Infections and infestations |
| |||
| Upper Respiratory Tract Infection Bacterial | Infections and infestations |
| |||
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders |
| |||
| Chest Pain | General disorders |
| |||
| Non-Cardiac Chest Pain | General disorders |
| |||
| Limb Injury | Injury, poisoning and procedural complications |
| |||
| Road Traffic Accident | Injury, poisoning and procedural complications |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Somatoform Disorder Gastrointestinal | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal 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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| Czechia |
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| United States |
|
| United Kingdom |
|