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CompletedNCT00655473Updated Jan 3, 2020Results posted

A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

A Phase 2 interventional study of Dalcetrapib (RO4607381) and Placebo in Coronary Heart Disease, sponsored by Hoffmann-La Roche. Completed at 12 sites in 2 countries. 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

Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.

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Conditions studied

  • Coronary Heart Disease
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In context

Heart Diseases

3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 130 is above the median of 100 across 1,779 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, including patients with other CHD risk factors;
  • treated appropriately for dyslipidemia;
  • clinically stable.

Exclusion criteria

Exclusion Criteria:

  • previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
  • recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
  • severe anemia;
  • uncontrolled hypertension;
  • poorly controlled diabetes.
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Study design

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

Study arms

  • Experimental
    Dalcetrapib (RO4607381)

    Drug: Dalcetrapib (RO4607381)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugDalcetrapib (RO4607381)

    600mg po daily for 24 months

  • DrugPlacebo

    po daily for 24 months

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Mean Wall Thickness

    Time frame: 24 months

  2. Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.

    Time frame: 6 months

Secondary outcomes

  1. Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance

    Time frame: 6 months

  2. Change From Baseline in Vessel MR Determined Plaque Anatomy

    Time frame: Up to 24 months

  3. Blood Lipids,Lipoproteins

    Time frame: Throughout study

  4. Biomarkers

    Time frame: Up to 24 months

  5. CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure

    Time frame: Throughout study

07

Results

Posted Jan 3, 2020

Participant flow

Participant flow — Overall Study
MilestoneDalcetrapib (RO4607381)Placebo
Started6466
Completed5351
Not completed1115

Outcome measures

PrimaryPercent Change From Baseline in Mean Wall Thickness
Time frame:
24 months
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline in Mean Wall Thickness
Percent ChangeDalcetrapib (RO4607381)Placebo
Percent Change From Baseline in Mean Wall Thickness4.245 ± 3.0186.679 ± 3.111
PrimaryChange From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
Time frame:
6 months
Reported as:
Least squares mean · Ratio
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
RatioDalcetrapib (RO4607381)Placebo
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.-0.188 ± 0.078-0.260 ± 0.079
SecondaryChange From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Time frame:
6 months

No measurements were reported for this outcome.

SecondaryChange From Baseline in Vessel MR Determined Plaque Anatomy
Time frame:
Up to 24 months

No measurements were reported for this outcome.

SecondaryBlood Lipids,Lipoproteins
Time frame:
Throughout study

No measurements were reported for this outcome.

SecondaryBiomarkers
Time frame:
Up to 24 months

No measurements were reported for this outcome.

SecondaryCHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Time frame:
Throughout study

No measurements were reported for this outcome.

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Dalcetrapib (RO4607381)—20/64 (31.3%)0/64 (0%)
Placebo—19/66 (28.8%)0/66 (0%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventDalcetrapib (RO4607381)Placebo
Non-Cardiac Chest PainGeneral disorders0/643/66
PneumoniaInfections and infestations2/641/66
BronchitisInfections and infestations2/640/66
Cardiac Failure CongestiveCardiac disorders2/640/66
OsteoarthritisMusculoskeletal and connective tissue disorders1/642/66
Intervertebral Disc ProtrusionMusculoskeletal and connective tissue disorders1/640/66
Spinal OsteoarthritisMusculoskeletal and connective tissue disorders1/640/66
Scrotal AbcessInfections and infestations1/640/66
Scrotal InfectionInfections and infestations1/640/66
Chest PainGeneral disorders1/640/66

Baseline characteristics

Age, Continuous
Age, Continuous(years)Dalcetrapib (RO4607381)PlaceboTotal
Mean62.6 ± 8.2464.6 ± 7.863.6 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)Dalcetrapib (RO4607381)PlaceboTotal
Female5155106
Male131124
Region of Enrollment
Region of Enrollment(participants)Dalcetrapib (RO4607381)PlaceboTotal
Canada8816
United States5658114
08

Study locations

12 sites
  • Jacksonville, Florida 32216, United States
  • Royal Oak, Michigan 48073, United States
  • Minneapolis, Minnesota 55455, United States
  • Kansas City, Missouri 64111, United States
  • New York, New York 10029, United States
  • Statesville, North Carolina 28677, United States
  • Cincinnati, Ohio 45219, United States
  • Cincinnati, Ohio 45227, United States
  • Cleveland, Ohio 44195, United States
  • Houston, Texas 77030, United States
  • Seattle, Washington 98108, United States
  • Montreal, Quebec H1T 1C8, Canada
09

References and documents

Publications

  • Duivenvoorden R, Mani V, Woodward M, Kallend D, Suchankova G, Fuster V, Rudd JHF, Tawakol A, Farkouh ME, Fayad ZA. Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study. JACC Cardiovasc Imaging. 2013 Oct;6(10):1087-1094. doi: 10.1016/j.jcmg.2013.03.009. PubMed 24135322 ↗
  • Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, Millon A, Rosenbaum D, Tawakol A, Woodward M, Bucerius J, Moshier E, Godbold J, Kallend D, Farkouh ME, Fuster V, Rudd JH, Fayad ZA. The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1884-93. doi: 10.1007/s00259-013-2518-4. Epub 2013 Aug 14. PubMed 23942908 ↗
  • Fayad ZA, Mani V, Woodward M, Kallend D, Abt M, Burgess T, Fuster V, Ballantyne CM, Stein EA, Tardif JC, Rudd JH, Farkouh ME, Tawakol A; dal-PLAQUE Investigators. Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet. 2011 Oct 29;378(9802):1547-59. doi: 10.1016/S0140-6736(11)61383-4. Epub 2011 Sep 9. PubMed 21908036 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00655473
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Apr 10, 2008
Start date
Mar 2008
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Jan 3, 2020
Last update
Jan 3, 2020

Study contacts

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

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