Trial Outcomes & Findings for A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease (NCT NCT00655473)
NCT ID: NCT00655473
Last Updated: 2020-01-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
24 months
Results posted on
2020-01-03
Participant Flow
Participant milestones
| Measure |
Dalcetrapib (RO4607381)
Dalcetrapib (RO4607381): 600mg po daily for 24 months
|
Placebo
Placebo: po daily for 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
|
Overall Study
COMPLETED
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
Baseline characteristics by cohort
| Measure |
Dalcetrapib (RO4607381)
n=64 Participants
Dalcetrapib (RO4607381): 600mg po daily for 24 months
|
Placebo
n=66 Participants
Placebo: po daily for 24 months
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
58 participants
n=7 Participants
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Dalcetrapib (RO4607381)
n=64 Participants
Dalcetrapib (RO4607381): 600mg po daily for 24 months
|
Placebo
n=66 Participants
Placebo: po daily for 24 months
|
|---|---|---|
|
Percent Change From Baseline in Mean Wall Thickness
|
4.245 Percent Change
Standard Error 3.018
|
6.679 Percent Change
Standard Error 3.111
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Dalcetrapib (RO4607381)
n=64 Participants
Dalcetrapib (RO4607381): 600mg po daily for 24 months
|
Placebo
n=66 Participants
Placebo: po daily for 24 months
|
|---|---|---|
|
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
|
-0.188 Ratio
Standard Error 0.078
|
-0.260 Ratio
Standard Error 0.079
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout studyPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Throughout studyPopulation: Data not collected
Outcome measures
Outcome data not reported
Adverse Events
Dalcetrapib (RO4607381)
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 19 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalcetrapib (RO4607381)
n=64 participants at risk
Dalcetrapib (RO4607381): 600mg po daily for 24 months
|
Placebo
n=66 participants at risk
Placebo: po daily for 24 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/64 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Pneumonia
|
3.1%
2/64 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
3.1%
2/64 • Number of events 2
|
0.00%
0/66
|
|
Infections and infestations
Scrotal Abcess
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Infections and infestations
Scrotal Infection
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/64
|
4.5%
3/66 • Number of events 3
|
|
General disorders
Chest Pain
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
General disorders
Stent-Graft Endoleak
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.1%
2/64 • Number of events 2
|
0.00%
0/66
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Metastatic
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/64
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Ischaemia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/66
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place