Coronary Heart Disease
Conditions
Brief summary
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.
Interventions
DRUGdalcetrapib
Oral doses of 600 mg once daily for 20 weeks
DRUGplacebo
Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=45 years of age * Patients admitted to the hospital for acute coronary syndrome (ACS) * Patients receiving guideline-based medical and dietary management of dyslipidemia
Exclusion criteria
* Symptomatic congestive heart failure (NYHA Class III or IV) * Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study * Uncontrolled hypertension * Uncontrolled diabetes * Severe anemia * Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment | 20 weeks |
| Percent Change From Baseline in Blood Lipid Levels | 20 weeks |
| 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 From Baseline in Apolipoprotein Levels | 20 weeks |
| Safety: Incidence of Adverse Events | 24 weeks |
| Percent Change From Baseline in Lipoprotein Levels | 20 weeks |
Countries
Czechia, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dalcetrapib dalcetrapib: Oral doses of 600 mg once daily for 20 weeks | 148 |
| Placebo placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks | 150 |
| Total | 298 |
Baseline characteristics
| Characteristic | Dalcetrapib | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 9.77 | 60.7 years STANDARD_DEVIATION 10.09 | 60.9 years STANDARD_DEVIATION 9.92 |
| Region of Enrollment Czechia | 74 participants | 75 participants | 149 participants |
| Region of Enrollment Netherlands | 50 participants | 52 participants | 102 participants |
| Region of Enrollment United Kingdom | 14 participants | 12 participants | 26 participants |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Male | 114 Participants | 116 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 148 | 8 / 150 |
| serious Total, serious adverse events | 10 / 148 | 13 / 150 |
Outcome results
Primary
Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment
Time frame: 4 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dalcetrapib | Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment | 43.8 Percentage raise in HDL-C Levels | Standard Error 2.5 |
| Placebo | Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment | 10.1 Percentage raise in HDL-C Levels | Standard Error 2.5 |
Secondary
Percent Change From Baseline in Apolipoprotein Levels
Time frame: 20 weeks
Secondary
Percent Change From Baseline in Blood Lipid Levels
Time frame: 20 weeks
Secondary
Percent Change From Baseline in Lipoprotein Levels
Time frame: 20 weeks
Secondary
Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment
Time frame: 20 weeks
Secondary
Safety: Incidence of Adverse Events
Time frame: 24 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
Time frame: 4 weeks