Trial Outcomes & Findings for A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C) (NCT NCT00697203)
NCT ID: NCT00697203
Last Updated: 2020-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
292 participants
Primary outcome timeframe
Week 12
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Dalcetrapib 300mg
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
76
|
68
|
74
|
74
|
|
Overall Study
COMPLETED
|
67
|
62
|
66
|
67
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
Baseline characteristics by cohort
| Measure |
Dalcetrapib 300mg
n=76 Participants
Pravastatin: 40mg po daily for 12 weeks
dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=68 Participants
Pravastatin: 40mg po daily for 12 weeks
dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=74 Participants
Pravastatin: 40mg po daily for 12 weeks
dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=74 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.53 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 10.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
234 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Outcome measures
| Measure |
Dalcetrapib 300mg
n=75 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=67 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=72 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=73 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Absolute Change From Baseline in HDL-C Level\n
|
17.18 mg/dL
Standard Error 2.19
|
31.42 mg/dL
Standard Error 2.29
|
36.45 mg/dL
Standard Error 2.24
|
2.31 mg/dL
Standard Error 2.18
|
PRIMARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
Dalcetrapib 300mg
n=75 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=67 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=72 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=73 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C Level\n
|
6.58 Percent change in mg/dL
Standard Error 0.84
|
11.90 Percent change in mg/dL
Standard Error 0.88
|
13.92 Percent change in mg/dL
Standard Error 0.86
|
0.73 Percent change in mg/dL
Standard Error 0.84
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Dalcetrapib 300mg
n=76 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=68 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=74 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=74 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Total Cholesterol
|
7.08 Percent change in mg/dL
Standard Error 1.45
|
12.58 Percent change in mg/dL
Standard Error 1.52
|
9.36 Percent change in mg/dL
Standard Error 1.48
|
1.35 Percent change in mg/dL
Standard Error 1.45
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Triglycerides
|
-5.95 Percent change in mg/dL
Standard Error 3.93
|
4.45 Percent change in mg/dL
Standard Error 4.11
|
-5.01 Percent change in mg/dL
Standard Error 4.02
|
-4.25 Percent change in mg/dL
Standard Error 3.93
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
HDL-C
|
17.18 Percent change in mg/dL
Standard Error 2.19
|
31.42 Percent change in mg/dL
Standard Error 2.29
|
36.45 Percent change in mg/dL
Standard Error 2.24
|
2.31 Percent change in mg/dL
Standard Error 2.18
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
LDL-C
|
8.51 Percent change in mg/dL
Standard Error 2.58
|
10.88 Percent change in mg/dL
Standard Error 2.73
|
5.28 Percent change in mg/dL
Standard Error 2.65
|
3.84 Percent change in mg/dL
Standard Error 2.59
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
HDL-2
|
52.10 Percent change in mg/dL
Standard Error 8.19
|
97.40 Percent change in mg/dL
Standard Error 8.82
|
121.2 Percent change in mg/dL
Standard Error 8.49
|
10.54 Percent change in mg/dL
Standard Error 8.86
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
HDL-3
|
11.95 Percent change in mg/dL
Standard Error 1.96
|
20.94 Percent change in mg/dL
Standard Error 2.11
|
23.56 Percent change in mg/dL
Standard Error 2.03
|
0.68 Percent change in mg/dL
Standard Error 2.12
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
ApoA1
|
7.03 Percent change in mg/dL
Standard Error 1.39
|
13.60 Percent change in mg/dL
Standard Error 1.44
|
14.90 Percent change in mg/dL
Standard Error 1.40
|
1.01 Percent change in mg/dL
Standard Error 1.46
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
ApoA2
|
3.82 Percent change in mg/dL
Standard Error 1.23
|
8.07 Percent change in mg/dL
Standard Error 1.33
|
8.36 Percent change in mg/dL
Standard Error 1.28
|
0.72 Percent change in mg/dL
Standard Error 1.33
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
ApoB
|
2.66 Percent change in mg/dL
Standard Error 1.90
|
4.62 Percent change in mg/dL
Standard Error 2.01
|
-1.64 Percent change in mg/dL
Standard Error 1.95
|
-0.71 Percent change in mg/dL
Standard Error 1.98
|
|
Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
LpA1
|
15.06 Percent change in mg/dL
Standard Error 3.59
|
22.68 Percent change in mg/dL
Standard Error 3.59
|
24.76 Percent change in mg/dL
Standard Error 3.40
|
3.32 Percent change in mg/dL
Standard Error 3.81
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Dalcetrapib 300mg
n=76 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=68 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=74 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=74 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Percent Change of Fasting Glucose Level
|
3.61 Percent change in mg/dL
Standard Error 1.69
|
6.03 Percent change in mg/dL
Standard Error 1.79
|
5.42 Percent change in mg/dL
Standard Error 1.72
|
3.00 Percent change in mg/dL
Standard Error 1.70
|
SECONDARY outcome
Timeframe: Through 9 MonthsPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and at 12 WeeksOutcome measures
| Measure |
Dalcetrapib 300mg
n=75 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=67 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=72 Participants
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=73 Participants
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
HDL-C/LDL-C
|
-3.76 Percent Change in Ratio
Standard Error 2.96
|
-16.0 Percent Change in Ratio
Standard Error 3.20
|
-19.4 Percent Change in Ratio
Standard Error 3.04
|
3.09 Percent Change in Ratio
Standard Error 2.95
|
|
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
ApoB/ApoA1
|
-4.97 Percent Change in Ratio
Standard Error 2.10
|
-5.79 Percent Change in Ratio
Standard Error 2.19
|
-12.7 Percent Change in Ratio
Standard Error 2.11
|
-1.84 Percent Change in Ratio
Standard Error 2.50
|
|
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
HDL-2/HDL-3
|
35.18 Percent Change in Ratio
Standard Error 5.88
|
63.40 Percent Change in Ratio
Standard Error 6.33
|
76.38 Percent Change in Ratio
Standard Error 6.10
|
8.89 Percent Change in Ratio
Standard Error 6.37
|
Adverse Events
Dalcetrapib 300mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dalcetrapib 600mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dalcetrapib 900mg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalcetrapib 300mg
n=76 participants at risk
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 300mg po daily for 12 weeks
|
Dalcetrapib 600mg
n=68 participants at risk
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 600mg po daily for 12 weeks
|
Dalcetrapib 900mg
n=74 participants at risk
Pravastatin: 40mg po daily for 12 weeks
Dalcetrapib: 900mg po daily for 12 weeks
|
Placebo
n=74 participants at risk
Placebo: po daily for 12 weeks
Pravastatin: 40mg po daily for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/76
|
0.00%
0/68
|
0.00%
0/74
|
1.4%
1/74
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/76
|
1.5%
1/68
|
0.00%
0/74
|
0.00%
0/74
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/76
|
1.5%
1/68
|
0.00%
0/74
|
0.00%
0/74
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.3%
1/76
|
0.00%
0/68
|
0.00%
0/74
|
0.00%
0/74
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/76
|
0.00%
0/68
|
0.00%
0/74
|
1.4%
1/74
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/76
|
0.00%
0/68
|
1.4%
1/74
|
0.00%
0/74
|
|
Musculoskeletal and connective tissue disorders
Muscle Tightness
|
0.00%
0/76
|
0.00%
0/68
|
1.4%
1/74
|
0.00%
0/74
|
|
Nervous system disorders
Headache
|
0.00%
0/76
|
0.00%
0/68
|
1.4%
1/74
|
0.00%
0/74
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/76
|
1.5%
1/68
|
0.00%
0/74
|
0.00%
0/74
|
|
General disorders
Malaise
|
0.00%
0/76
|
1.5%
1/68
|
0.00%
0/74
|
0.00%
0/74
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place