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CompletedNCT00655538Updated Jan 2, 2020Results posted

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

A Phase 2 interventional study of Placebo and dalcetrapib in Coronary Heart Disease, sponsored by Hoffmann-La Roche. Completed at 23 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
476
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Coronary Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 476 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
476 participants (actual)

Study arms

  • Experimental
    Dalcetrapib

    Drug: dalcetrapib

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPlacebo

    po daily for 36 weeks

  • Drugdalcetrapib

    600mg po daily for 36 weeks

06

What researchers measure

Primary outcomes

  1. Change From Baseline in % Flow Mediated Dilatation (FMD)

    Time frame: Baseline and 12 weeks

  2. Change From Baseline in Mean BP, Measured by BP Monitoring

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. Change From Baseline in % FMD

    Time frame: baseline and 36 weeks

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

    Time frame: Baseline to 36 weeks

  3. CETP Activity

    Time frame: Up to 36 weeks

  4. 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

  5. Change From Baseline in Mean BP, Measured by BP Monitoring

    Time frame: Up to 36 weeks

  6. Percent Change CETP Mass

    Time frame: baseline to 36 weeks

07

Results

Posted Jan 2, 2020

Participant flow

Participant flow — Overall Study
MilestoneDalcetrapibPlacebo
Started238238
Completed214211
Not completed2427

Outcome measures

PrimaryChange From Baseline in % Flow Mediated Dilatation (FMD)
Time frame:
Baseline and 12 weeks
Reported as:
Least squares mean · %FMD
Change From Baseline in % Flow Mediated Dilatation (FMD)
%FMDDalcetrapibPlacebo
Change From Baseline in % Flow Mediated Dilatation (FMD)0.09 ± 0.130.32 ± 0.13
PrimaryChange From Baseline in Mean BP, Measured by BP Monitoring
Time frame:
Baseline and 4 weeks
Reported as:
Mean · mmHg
Change From Baseline in Mean BP, Measured by BP Monitoring
mmHgDalcetrapibPlacebo
Change From Baseline in Mean BP, Measured by BP Monitoring0.91 ± 0.570.31 ± 0.57
SecondaryChange From Baseline in % FMD
Time frame:
baseline and 36 weeks
Reported as:
Least squares mean · %FMD
Change From Baseline in % FMD
%FMDDalcetrapibPlacebo
Change From Baseline in % FMD10.50 ± 6.2720.13 ± 5.95
SecondaryPercent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Time frame:
Baseline to 36 weeks
Reported as:
Least squares mean · Percent change in mg/dL
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Percent change in mg/dLDalcetrapibPlacebo
HDL-C30.70 ± 1.45-0.14 ± 1.42
LDL-C4.43 ± 2.228.72 ± 2.18
Total Cholesterol8.66 ± 1.205.90 ± 1.18
Triglycerides-2.58 ± 2.6611.62 ± 2.61
ApoA112.84 ± 0.972.61 ± 0.96
ApoB-2.70 ± 1.231.98 ± 1.21
SecondaryCETP Activity
Time frame:
Up to 36 weeks
Reported as:
Least squares mean · Percent change pMOL/uL/hr
CETP Activity
Percent change pMOL/uL/hrDalcetrapibPlacebo
CETP Activity-48.66 ± 2.127.37 ± 2.09
SecondaryPercent 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
Reported as:
Mean · Percent change in ng/mL
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
Percent change in ng/mLDalcetrapibPlacebo
sP-Selectin-1.83 ± 1.580.24 ± 1.54
sE-Selectin6.01 ± 1.956.08 ± 1.90
Soluble intracellular adhesion molecule1.05 ± 0.952.01 ± 0.94
Soluble vascular cell molecule3.60 ± 0.791.86 ± 0.78
Lipoprotein-associated phospholipaseA2s23.24 ± 3.345.80 ± 3.29
Matrix metalloproteinase-33.46 ± 2.123.44 ± 2.07
Matrix metalloproteinase928.12 ± 10.9720.36 ± 10.75
SecondaryChange From Baseline in Mean BP, Measured by BP Monitoring
Time frame:
Up to 36 weeks
Reported as:
Mean · mmHg
Change From Baseline in Mean BP, Measured by BP Monitoring
mmHgDalcetrapibPlacebo
Change From Baseline in Mean BP, Measured by BP Monitoring1.93 ± 0.601.17 ± 0.59
SecondaryPercent Change CETP Mass
Time frame:
baseline to 36 weeks
Reported as:
Least squares mean · Percent change in ug/mL
Percent Change CETP Mass
Percent change in ug/mLDalcetrapibPlacebo
Percent Change CETP Mass94.19 ± 2.705.17 ± 2.65

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dalcetrapib0/236 (0%)12/236 (5.1%)92/236 (39%)
Placebo1/236 (0.4%)14/236 (5.9%)112/236 (47.5%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventDalcetrapibPlacebo
Angina PectorisCardiac disorders1/2362/236
Angina UnstableCardiac disorders1/2360/236
Atrial FibrilationCardiac disorders1/2360/236
Cardiac Failure CongestiveCardiac disorders0/2361/236
AppendicitisInfections and infestations0/2361/236
Appendicitis PerforatedInfections and infestations0/2361/236
BronchitisInfections and infestations1/2360/236
OrchitisInfections and infestations1/2360/236
PneumoniaInfections and infestations0/2361/236
Viral InfectionInfections and infestations1/2360/236
Most frequent other events
Most frequent other events
EventDalcetrapibPlacebo
NasopharyngitisInfections and infestations38/23642/236
DiarrheaGastrointestinal disorders27/23626/236
Back PainMusculoskeletal and connective tissue disorders8/23616/236
InfluenzaInfections and infestations9/23615/236
HeadacheNervous system disorders10/23613/236

Baseline characteristics

Age, Continuous
Age, Continuous(years)DalcetrapibPlaceboTotal
Mean62.3 ± 7.0561.9 ± 7.9262.1 ± 7.56
Sex: Female, Male
Sex: Female, Male(Participants)DalcetrapibPlaceboTotal
Female211211422
Male212344
08

Study locations

23 sites
  • Feldkirch, 6800, Austria
  • Paris, 75908, France
  • Bonn, 53127, Germany
  • Dortmund, 44137, Germany
  • Frankfurt, 60596, Germany
  • Mainz, 55131, Germany
  • Wuppertal, 42117, Germany
  • Pisa, Toscana 56100, Italy
  • Amsterdam, 1105 AZ, Netherlands
  • Breda, 4811 SW, Netherlands
  • Eindhoven, 5611 NJ, Netherlands
  • Goes, 4462 RA, Netherlands
  • Groningen, 9711 SG, Netherlands
  • Hoorn, 1625 HV, Netherlands
  • Leiderdorp, 2352 RA, Netherlands
  • Nijmegen, 6525 EC, Netherlands
  • Rotterdam, 3021 HC, Netherlands
  • Utrecht, 3508 GA, Netherlands
  • Velp, 6883 ES, Netherlands
  • Zoetermeer, 2724 EK, Netherlands
  • Lugano, 6900, Switzerland
  • Zürich, 8091, Switzerland
  • Cardiff, CF14 4XN, United Kingdom
09

References and documents

Publications

  • Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16. PubMed 22345126 ↗
  • Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Munzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Luscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6. PubMed 21128879 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00655538
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 10, 2008
Start date
Feb 2008
Primary completion
May 2010
Completion
May 2010
Results posted
Jan 2, 2020
Last update
Jan 2, 2020

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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