Trial Outcomes & Findings for A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381 (NCT NCT00400439)
NCT ID: NCT00400439
Last Updated: 2020-01-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
Results posted on
2020-01-03
Participant Flow
Participant milestones
| Measure |
Dalcetrapib (RO4607381)
dalcetrapib (RO4607381): 900mg po daily for 24 weeks
|
Placebo
placebo: po daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
25
|
|
Overall Study
COMPLETED
|
47
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Baseline characteristics by cohort
| Measure |
Dalcetrapib (RO4607381)
n=52 Participants
dalcetrapib (RO4607381): 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
placebo: po daily for 24 weeks
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 7.03 • n=39 Participants
|
60.8 years
STANDARD_DEVIATION 7.83 • n=41 Participants
|
60.6 years
STANDARD_DEVIATION 7.19 • n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))Outcome measures
| Measure |
Dalcetrapib (RO4607381)
n=52 Participants
dalcetrapib (RO4607381): 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
placebo: po daily for 24 weeks
|
|---|---|---|
|
Percent Change From Baseline in HDL-C
|
33.76 Percentage Change of HDL-C
Standard Error 4.43
|
3.69 Percentage Change of HDL-C
Standard Error 5.81
|
SECONDARY outcome
Timeframe: Baseline and Week 24 (Week 48 from start of NC19453)Outcome measures
| Measure |
Dalcetrapib (RO4607381)
n=52 Participants
dalcetrapib (RO4607381): 900mg po daily for 24 weeks
|
Placebo
n=25 Participants
placebo: po daily for 24 weeks
|
|---|---|---|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
HDL-C
|
37.29 mg/dL
Standard Error 5.11
|
2.98 mg/dL
Standard Error 6.08
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Total Cholesterol
|
16.60 mg/dL
Standard Error 5.17
|
-0.96 mg/dL
Standard Error 6.16
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
LDL-C
|
7.54 mg/dL
Standard Error 5.12
|
2.16 mg/dL
Standard Error 6.13
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Triglycerides
|
2.95 mg/dL
Standard Error 21.44
|
-8.10 mg/dL
Standard Error 25.91
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
ApoB
|
4.02 mg/dL
Standard Error 3.36
|
-0.79 mg/dL
Standard Error 4.09
|
|
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
ApoA1
|
25.13 mg/dL
Standard Error 3.55
|
8.91 mg/dL
Standard Error 4.28
|
Adverse Events
Dalcetrapib (RO4607381)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place