A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease
A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors
1 other identifier
interventional
130
2 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
January 3, 2020
CompletedJanuary 3, 2020
December 1, 2019
2.7 years
March 28, 2008
July 17, 2019
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Mean Wall Thickness
24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
6 months
Secondary Outcomes (5)
Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
6 months
Change From Baseline in Vessel MR Determined Plaque Anatomy
Up to 24 months
Blood Lipids,Lipoproteins
Throughout study
Biomarkers
Up to 24 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Throughout study
Study Arms (2)
Dalcetrapib (RO4607381)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients, 18-75 years of age;
- CHD, including patients with other CHD risk factors;
- treated appropriately for dyslipidemia;
- clinically stable.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Royal Oak, Michigan, 48073, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Seattle, Washington, 98108, United States
Unknown Facility
Montreal, Quebec, H1T 1C8, Canada
Related Publications (3)
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.
PMID: 24135322DERIVEDCalcagno 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.
PMID: 23942908DERIVEDFayad 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.
PMID: 21908036DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Black
- Organization
- DalCor Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 10, 2008
Study Start
March 1, 2008
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 3, 2020
Results First Posted
January 3, 2020
Record last verified: 2019-12