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A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00655538
Enrollment
476
Registered
2008-04-10
Start date
2008-02-29
Completion date
2010-05-31
Last updated
2020-01-02

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 study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Interventions

DRUGPlacebo

po daily for 36 weeks

DRUGdalcetrapib

600mg po daily for 36 weeks

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

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
No

Inclusion criteria

* adult patients, 18-75 years of age; * CHD or CHD risk equivalent; * appropriately treated for accepted LDL-C level.

Exclusion criteria

* treatment with drugs raising HDL-C (eg niacin, fibrates); * uncontrolled hypertension; * recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident; * severe anemia; * poorly controlled diabetes.

Design outcomes

Primary

MeasureTime frame
Change From Baseline in % Flow Mediated Dilatation (FMD)Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP MonitoringBaseline and 4 weeks

Secondary

MeasureTime frame
CETP ActivityUp to 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 metalloproteinase9Baseline and 36 weeks
Change From Baseline in % FMDbaseline and 36 weeks
Percent Change CETP Massbaseline to 36 weeks
Change From Baseline in Mean BP, Measured by BP MonitoringUp to 36 weeks
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBBaseline to 36 weeks

Countries

Austria, France, Germany, Italy, Netherlands, Switzerland, United Kingdom

Participant flow

Participants by arm

ArmCount
Dalcetrapib
dalcetrapib: 600mg po daily for 36 weeks
232
Placebo
Placebo: po daily for 36 weeks
234
Total466

Baseline characteristics

CharacteristicDalcetrapibPlaceboTotal
Age, Continuous62.3 years
STANDARD_DEVIATION 7.05
61.9 years
STANDARD_DEVIATION 7.92
62.1 years
STANDARD_DEVIATION 7.56
Sex: Female, Male
Female
211 Participants211 Participants422 Participants
Sex: Female, Male
Male
21 Participants23 Participants44 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2361 / 236
other
Total, other adverse events
92 / 236112 / 236
serious
Total, serious adverse events
12 / 23614 / 236

Outcome results

Primary

Change From Baseline in % Flow Mediated Dilatation (FMD)

Time frame: Baseline and 12 weeks

Population: 10 subjects dropped before week 12

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DalcetrapibChange From Baseline in % Flow Mediated Dilatation (FMD)0.09 %FMDStandard Error 0.13
PlaceboChange From Baseline in % Flow Mediated Dilatation (FMD)0.32 %FMDStandard Error 0.13
Primary

Change From Baseline in Mean BP, Measured by BP Monitoring

Time frame: Baseline and 4 weeks

Population: not all participants were tested

ArmMeasureValue (MEAN)Dispersion
DalcetrapibChange From Baseline in Mean BP, Measured by BP Monitoring0.91 mmHgStandard Error 0.57
PlaceboChange From Baseline in Mean BP, Measured by BP Monitoring0.31 mmHgStandard Error 0.57
Secondary

CETP Activity

Time frame: Up to 36 weeks

Population: not all participants were tested

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DalcetrapibCETP Activity-48.66 Percent change pMOL/uL/hrStandard Error 2.12
PlaceboCETP Activity7.37 Percent change pMOL/uL/hrStandard Error 2.09
Secondary

Change From Baseline in % FMD

Time frame: baseline and 36 weeks

Population: not all participants were tested

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DalcetrapibChange From Baseline in % FMD10.50 %FMDStandard Deviation 6.27
PlaceboChange From Baseline in % FMD20.13 %FMDStandard Deviation 5.95
Secondary

Change From Baseline in Mean BP, Measured by BP Monitoring

Time frame: Up to 36 weeks

Population: not all participants were tested

ArmMeasureValue (MEAN)Dispersion
DalcetrapibChange From Baseline in Mean BP, Measured by BP Monitoring1.93 mmHgStandard Error 0.6
PlaceboChange From Baseline in Mean BP, Measured by BP Monitoring1.17 mmHgStandard Error 0.59
Secondary

Percent Change CETP Mass

Time frame: baseline to 36 weeks

Population: not all participants were tested

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
DalcetrapibPercent Change CETP Mass94.19 Percent change in ug/mLStandard Error 2.7
PlaceboPercent Change CETP Mass5.17 Percent change in ug/mLStandard Error 2.65
Secondary

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

Time frame: Baseline and 36 weeks

Population: not all participants were tested

ArmMeasureGroupValue (MEAN)Dispersion
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Soluble intracellular adhesion molecule1.05 Percent change in ng/mLStandard Error 0.95
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Lipoprotein-associated phospholipaseA2s23.24 Percent change in ng/mLStandard Error 3.34
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9sE-Selectin6.01 Percent change in ng/mLStandard Error 1.95
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Matrix metalloproteinase-33.46 Percent change in ng/mLStandard Error 2.12
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Soluble vascular cell molecule3.60 Percent change in ng/mLStandard Error 0.79
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Matrix metalloproteinase928.12 Percent change in ng/mLStandard Error 10.97
DalcetrapibPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9sP-Selectin-1.83 Percent change in ng/mLStandard Error 1.58
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Matrix metalloproteinase920.36 Percent change in ng/mLStandard Error 10.75
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9sP-Selectin0.24 Percent change in ng/mLStandard Error 1.54
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9sE-Selectin6.08 Percent change in ng/mLStandard Error 1.9
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Soluble intracellular adhesion molecule2.01 Percent change in ng/mLStandard Error 0.94
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Soluble vascular cell molecule1.86 Percent change in ng/mLStandard Error 0.78
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Lipoprotein-associated phospholipaseA2s5.80 Percent change in ng/mLStandard Error 3.29
PlaceboPercent Change From Baseline of sP-Selectin, sE-Selectin, Soluble Intracellular Adhesion Molecule, Soluble Vascular Cell Molecule, Lipoprotein-associated phospholipaseA2s, Matrix Metalloproteinase-3, Matrix metalloproteinase9Matrix metalloproteinase-33.44 Percent change in ng/mLStandard Error 2.07
Secondary

Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB

Time frame: Baseline to 36 weeks

Population: not all participants were tested

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBLDL-C4.43 Percent change in mg/dLStandard Error 2.22
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBTriglycerides-2.58 Percent change in mg/dLStandard Error 2.66
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBApoA112.84 Percent change in mg/dLStandard Error 0.97
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBHDL-C30.70 Percent change in mg/dLStandard Error 1.45
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBApoB-2.70 Percent change in mg/dLStandard Error 1.23
DalcetrapibPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBTotal Cholesterol8.66 Percent change in mg/dLStandard Error 1.2
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBApoB1.98 Percent change in mg/dLStandard Error 1.21
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBHDL-C-0.14 Percent change in mg/dLStandard Error 1.42
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBLDL-C8.72 Percent change in mg/dLStandard Error 2.18
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBTotal Cholesterol5.90 Percent change in mg/dLStandard Error 1.18
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBApoA12.61 Percent change in mg/dLStandard Error 0.96
PlaceboPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoBTriglycerides11.62 Percent change in mg/dLStandard Error 2.61

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026