A Phase 2 interventional study of dalcetrapib (RO4607381) and placebo in Coronary Heart Disease, sponsored by Hoffmann-La Roche. Completed at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-03.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 77 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: dalcetrapib (RO4607381)
Drug: placebo
900mg po daily for 24 weeks
po daily for 24 weeks
Percent Change From Baseline in HDL-C
Time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))
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)
Time frame: Baseline and Week 24 (Week 48 from start of NC19453)
| Milestone | Dalcetrapib (RO4607381) | Placebo |
|---|---|---|
| Started | 52 | 25 |
| Completed | 47 | 23 |
| Not completed | 5 | 2 |
| Percentage Change of HDL-C | Dalcetrapib (RO4607381) | Placebo |
|---|---|---|
| Percent Change From Baseline in HDL-C | 33.76 ± 4.43 | 3.69 ± 5.81 |
| mg/dL | Dalcetrapib (RO4607381) | Placebo |
|---|---|---|
| HDL-C | 37.29 ± 5.11 | 2.98 ± 6.08 |
| Total Cholesterol | 16.60 ± 5.17 | -0.96 ± 6.16 |
| LDL-C | 7.54 ± 5.12 | 2.16 ± 6.13 |
| Triglycerides | 2.95 ± 21.44 | -8.10 ± 25.91 |
| ApoB | 4.02 ± 3.36 | -0.79 ± 4.09 |
| ApoA1 | 25.13 ± 3.55 | 8.91 ± 4.28 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dalcetrapib (RO4607381) | — | — | — |
| Placebo | — | — | — |
| Age, Continuous(years) | Dalcetrapib (RO4607381) | Placebo | Total |
|---|---|---|---|
| Mean | 60.6 ± 7.03 | 60.8 ± 7.83 | 60.6 ± 7.19 |
| Sex: Female, Male(Participants) | Dalcetrapib (RO4607381) | Placebo | Total |
|---|---|---|---|
| Female | 12 | 3 | 15 |
| Male | 40 | 22 | 62 |
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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