A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400439

Enrollment

Registered

2006-11-16

Start date

2007-01-31

Completion date

2008-01-31

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Brief summary

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.

Interventions

DRUGdalcetrapib (RO4607381)

900mg po daily for 24 weeks

DRUGplacebo

po daily for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* patients who have completed treatment on study NC19453.

Exclusion criteria

* any significant lymph node abnormalities at the end of study NC19453.

Design outcomes

Primary

Measure	Time frame
Percent Change From Baseline in HDL-C	Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))

Secondary

Measure	Time frame
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)	Baseline and Week 24 (Week 48 from start of NC19453)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Dalcetrapib (RO4607381) dalcetrapib (RO4607381): 900mg po daily for 24 weeks	52
Placebo placebo: po daily for 24 weeks	25
Total	77

Baseline characteristics

Characteristic	Dalcetrapib (RO4607381)	Placebo	Total
Age, Continuous	60.6 years STANDARD_DEVIATION 7.03	60.8 years STANDARD_DEVIATION 7.83	60.6 years STANDARD_DEVIATION 7.19
Sex: Female, Male Female	12 Participants	3 Participants	15 Participants
Sex: Female, Male Male	40 Participants	22 Participants	62 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Percent Change From Baseline in HDL-C

Time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Dalcetrapib (RO4607381)	Percent Change From Baseline in HDL-C	33.76 Percentage Change of HDL-C	Standard Error 4.43
Placebo	Percent Change From Baseline in HDL-C	3.69 Percentage Change of HDL-C	Standard Error 5.81

Secondary

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)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Dalcetrapib (RO4607381)	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
Dalcetrapib (RO4607381)	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
Dalcetrapib (RO4607381)	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
Dalcetrapib (RO4607381)	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
Dalcetrapib (RO4607381)	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
Dalcetrapib (RO4607381)	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
Placebo	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	-0.79 mg/dL	Standard Error 4.09
Placebo	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	2.98 mg/dL	Standard Error 6.08
Placebo	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	-8.10 mg/dL	Standard Error 25.91
Placebo	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	-0.96 mg/dL	Standard Error 6.16
Placebo	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	8.91 mg/dL	Standard Error 4.28
Placebo	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	2.16 mg/dL	Standard Error 6.13

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Percent Change From Baseline in HDL-C

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)