Trial Outcomes & Findings for A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients (NCT NCT00655538)
NCT ID: NCT00655538
Last Updated: 2020-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
476 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Dalcetrapib
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
238
|
|
Overall Study
COMPLETED
|
214
|
211
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
Baseline characteristics by cohort
| Measure |
Dalcetrapib
n=232 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=234 Participants
Placebo: po daily for 36 weeks
|
Total
n=466 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 7.05 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 7.92 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 7.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: 10 subjects dropped before week 12
Outcome measures
| Measure |
Dalcetrapib
n=232 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=234 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Change From Baseline in % Flow Mediated Dilatation (FMD)
|
0.09 %FMD
Standard Error 0.13
|
0.32 %FMD
Standard Error 0.13
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=235 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=237 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Change From Baseline in Mean BP, Measured by BP Monitoring
|
0.91 mmHg
Standard Error 0.57
|
0.31 mmHg
Standard Error 0.57
|
SECONDARY outcome
Timeframe: baseline and 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=232 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=234 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Change From Baseline in % FMD
|
10.50 %FMD
Standard Deviation 6.27
|
20.13 %FMD
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=207 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=211 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
HDL-C
|
30.70 Percent change in mg/dL
Standard Error 1.45
|
-0.14 Percent change in mg/dL
Standard Error 1.42
|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
LDL-C
|
4.43 Percent change in mg/dL
Standard Error 2.22
|
8.72 Percent change in mg/dL
Standard Error 2.18
|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Total Cholesterol
|
8.66 Percent change in mg/dL
Standard Error 1.20
|
5.90 Percent change in mg/dL
Standard Error 1.18
|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Triglycerides
|
-2.58 Percent change in mg/dL
Standard Error 2.66
|
11.62 Percent change in mg/dL
Standard Error 2.61
|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
ApoA1
|
12.84 Percent change in mg/dL
Standard Error 0.97
|
2.61 Percent change in mg/dL
Standard Error 0.96
|
|
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
ApoB
|
-2.70 Percent change in mg/dL
Standard Error 1.23
|
1.98 Percent change in mg/dL
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=207 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=210 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
CETP Activity
|
-48.66 Percent change pMOL/uL/hr
Standard Error 2.12
|
7.37 Percent change pMOL/uL/hr
Standard Error 2.09
|
SECONDARY outcome
Timeframe: Baseline and 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=207 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=211 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Matrix metalloproteinase9
|
28.12 Percent change in ng/mL
Standard Error 10.97
|
20.36 Percent change in ng/mL
Standard Error 10.75
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
sP-Selectin
|
-1.83 Percent change in ng/mL
Standard Error 1.58
|
0.24 Percent change in ng/mL
Standard Error 1.54
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
sE-Selectin
|
6.01 Percent change in ng/mL
Standard Error 1.95
|
6.08 Percent change in ng/mL
Standard Error 1.90
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Soluble intracellular adhesion molecule
|
1.05 Percent change in ng/mL
Standard Error 0.95
|
2.01 Percent change in ng/mL
Standard Error 0.94
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Soluble vascular cell molecule
|
3.60 Percent change in ng/mL
Standard Error 0.79
|
1.86 Percent change in ng/mL
Standard Error 0.78
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Lipoprotein-associated phospholipaseA2s
|
23.24 Percent change in ng/mL
Standard Error 3.34
|
5.80 Percent change in ng/mL
Standard Error 3.29
|
|
Percent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9
Matrix metalloproteinase-3
|
3.46 Percent change in ng/mL
Standard Error 2.12
|
3.44 Percent change in ng/mL
Standard Error 2.07
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=235 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=237 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Change From Baseline in Mean BP, Measured by BP Monitoring
|
1.93 mmHg
Standard Error 0.60
|
1.17 mmHg
Standard Error 0.59
|
SECONDARY outcome
Timeframe: baseline to 36 weeksPopulation: not all participants were tested
Outcome measures
| Measure |
Dalcetrapib
n=207 Participants
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=211 Participants
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Percent Change CETP Mass
|
94.19 Percent change in ug/mL
Standard Error 2.70
|
5.17 Percent change in ug/mL
Standard Error 2.65
|
Adverse Events
Dalcetrapib
Serious events: 12 serious events
Other events: 92 other events
Deaths: 0 deaths
Placebo
Serious events: 14 serious events
Other events: 112 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dalcetrapib
n=236 participants at risk
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=236 participants at risk
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.42%
1/236
|
0.85%
2/236
|
|
Cardiac disorders
Angina Unstable
|
0.42%
1/236
|
0.00%
0/236
|
|
Cardiac disorders
Atrial Fibrilation
|
0.42%
1/236
|
0.00%
0/236
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/236
|
0.42%
1/236
|
|
Infections and infestations
Appendicitis
|
0.00%
0/236
|
0.42%
1/236
|
|
Infections and infestations
Appendicitis Perforated
|
0.00%
0/236
|
0.42%
1/236
|
|
Infections and infestations
Bronchitis
|
0.42%
1/236
|
0.00%
0/236
|
|
Infections and infestations
Orchitis
|
0.42%
1/236
|
0.00%
0/236
|
|
Infections and infestations
Pneumonia
|
0.00%
0/236
|
0.42%
1/236
|
|
Infections and infestations
Viral Infection
|
0.42%
1/236
|
0.00%
0/236
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
|
0.00%
0/236
|
0.42%
1/236
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.42%
1/236
|
0.00%
0/236
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/236
|
0.42%
1/236
|
|
Nervous system disorders
Dizziness
|
0.42%
1/236
|
0.00%
0/236
|
|
Nervous system disorders
Migrane
|
0.00%
0/236
|
0.42%
1/236
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.42%
1/236
|
0.00%
0/236
|
|
General disorders
Pain
|
0.42%
1/236
|
0.00%
0/236
|
|
General disorders
Purexia
|
0.00%
0/236
|
0.42%
1/236
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.42%
1/236
|
0.00%
0/236
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/236
|
0.42%
1/236
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/236
|
0.42%
1/236
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/236
|
0.42%
1/236
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.42%
1/236
|
0.00%
0/236
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.42%
1/236
|
0.00%
0/236
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.42%
1/236
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.00%
0/236
|
0.42%
1/236
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/236
|
0.42%
1/236
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
0.00%
0/236
|
0.42%
1/236
|
Other adverse events
| Measure |
Dalcetrapib
n=236 participants at risk
dalcetrapib: 600mg po daily for 36 weeks
|
Placebo
n=236 participants at risk
Placebo: po daily for 36 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.1%
38/236
|
17.8%
42/236
|
|
Infections and infestations
Influenza
|
3.8%
9/236
|
6.4%
15/236
|
|
Gastrointestinal disorders
Diarrhea
|
11.4%
27/236
|
11.0%
26/236
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
8/236
|
6.8%
16/236
|
|
Nervous system disorders
Headache
|
4.2%
10/236
|
5.5%
13/236
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place