Trial Outcomes & Findings for A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE) (NCT NCT01323153)
NCT ID: NCT01323153
Last Updated: 2019-07-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-07-30
Participant Flow
Participant milestones
| Measure |
Dalcetrapib
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
|
Placebo
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
133
|
142
|
|
Overall Study
NOT COMPLETED
|
17
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Dalcetrapib in Patients Hospitalized For An Acute Coronary Syndrome (Dal-ACUTE)
Baseline characteristics by cohort
| Measure |
Dalcetrapib
n=148 Participants
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
|
Placebo
n=150 Participants
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 9.77 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 10.09 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
50 participants
n=5 Participants
|
52 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
74 participants
n=5 Participants
|
75 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Dalcetrapib
n=148 Participants
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
|
Placebo
n=150 Participants
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
|
|---|---|---|
|
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
|
10.1 Percentage raise in HDL-C Levels
Standard Error 2.5
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
Adverse Events
Dalcetrapib
Serious events: 10 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalcetrapib
n=148 participants at risk
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
|
Placebo
n=150 participants at risk
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Cardiac disorders
Atrial Fibrillation
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Cardiac disorders
Supraventricular Tachicardia
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Cardiac disorders
Ventricular Tachicardia
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid Cancer
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Haemorhage
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Infections and infestations
Mycobacterial Infection
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Upper Respiratory Tract Infection Bacterial
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
General disorders
Chest Pain
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
General disorders
Non-Cardiac Chest Pain
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Syncope
|
0.68%
1/148 • Number of events 1
|
0.00%
0/150
|
|
Psychiatric disorders
Somatoform Disorder Gastrointestinal
|
0.00%
0/148
|
0.67%
1/150 • Number of events 1
|
Other adverse events
| Measure |
Dalcetrapib
n=148 participants at risk
dalcetrapib: Oral doses of 600 mg once daily for 20 weeks
|
Placebo
n=150 participants at risk
placebo: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
7/148 • Number of events 7
|
5.3%
8/150 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place