Trial Outcomes & Findings for A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent. (NCT NCT00353522)
NCT ID: NCT00353522
Last Updated: 2020-01-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
Dalcetrapib
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
46
|
|
Overall Study
COMPLETED
|
74
|
37
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Baseline characteristics by cohort
| Measure |
Dalcetrapib
n=89 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=46 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 7.50 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 7.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Dalcetrapib
n=89 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=45 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Absolute Change From Baseline in HDL-C
|
12.76 mg/dL
Standard Error 1.17
|
0.50 mg/dL
Standard Error 1.49
|
PRIMARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Dalcetrapib
n=89 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=45 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Percent Change From Baseline in HDL-C
|
33.40 Percent Change
Standard Error 2.86
|
3.59 Percent Change
Standard Error 3.64
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24Outcome measures
| Measure |
Dalcetrapib
n=52 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass
|
86.45 Percent change
Standard Error 6.30
|
-4.93 Percent change
Standard Error 8.32
|
SECONDARY outcome
Timeframe: Baseline and 48 WeeksOutcome measures
| Measure |
Dalcetrapib
n=84 Number of Mesenteric Lymph Nodes
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=41 Number of Mesenteric Lymph Nodes
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Change in Mesenteric Lymph Nodes
Number Increased in Volume
|
4 Number of Nodes
|
11 Number of Nodes
|
|
Change in Mesenteric Lymph Nodes
Number Decreased in Volume
|
6 Number of Nodes
|
18 Number of Nodes
|
SECONDARY outcome
Timeframe: Baseline and 48 WeeksOutcome measures
| Measure |
Dalcetrapib
n=52 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
Total Cholesterol
|
10.17 Percent change in mg/dL
Standard Error 3.20
|
2.67 Percent change in mg/dL
Standard Error 4.22
|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
Triglycerides
|
0.94 Percent change in mg/dL
Standard Error 8.76
|
4.11 Percent change in mg/dL
Standard Error 11.63
|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
HDL-C
|
33.76 Percent change in mg/dL
Standard Error 4.43
|
3.69 Percent change in mg/dL
Standard Error 5.81
|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
LDL-C
|
4.75 Percent change in mg/dL
Standard Error 4.45
|
2.97 Percent change in mg/dL
Standard Error 5.87
|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
ApoA1
|
16.43 Percent change in mg/dL
Standard Error 2.54
|
8.15 Percent change in mg/dL
Standard Error 3.30
|
|
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
ApoB
|
4.98 Percent change in mg/dL
Standard Error 3.83
|
2.48 Percent change in mg/dL
Standard Error 5.00
|
SECONDARY outcome
Timeframe: Baseline and 48 WeeksOutcome measures
| Measure |
Dalcetrapib
n=52 Participants
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity
|
-56.5 percent change in pMOL/mcL/hr
Standard Error 5.09
|
-5.69 percent change in pMOL/mcL/hr
Standard Error 6.67
|
Adverse Events
Dalcetrapib
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalcetrapib
n=89 participants at risk
Dalcetrapib 900mg po daily for 24 weeks
dalcetrapib: 900mg po daily for 24 weeks
|
Placebo
n=46 participants at risk
Placebo po daily for 24 weeks
Placebo: po daily for 24 weeks
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.2%
2/89
|
0.00%
0/46
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
1/89
|
2.2%
1/46
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
1/89
|
0.00%
0/46
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
1/89
|
4.3%
2/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
1.1%
1/89
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Squamous Cell Carcinoma
|
1.1%
1/89
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
1.1%
1/89
|
0.00%
0/46
|
|
General disorders
Non-Cardiac Chest Pain
|
2.2%
2/89
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/89
|
2.2%
1/46
|
|
Musculoskeletal and connective tissue disorders
OsteoArthritis
|
0.00%
0/89
|
2.2%
1/46
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/89
|
2.2%
1/46
|
|
Infections and infestations
Nerocysterosis
|
1.1%
1/89
|
0.00%
0/46
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place