NCT00655473 is a Phase 2 clinical trial of Dalcetrapib (RO4607381) in Coronary Heart Disease, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT00655473?

NCT00655473 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00655473?

Interventions in NCT00655473: Dalcetrapib (RO4607381), Placebo.

What condition does NCT00655473 study?

NCT00655473 studies Coronary Heart Disease.

Is NCT00655473 still recruiting?

NCT00655473 is currently completed. Last updated 16 December 2019.

Are results published for NCT00655473?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-16 · How we verify

NCT00655473

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 16 December 2019

What this trial tests

Phase 2 trial testing Dalcetrapib (RO4607381) in Coronary Heart Disease in 130 participants. Completed in 1 November 2010.

Timeline

1 March 2008

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	130
Start date	1 March 2008
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	12 locations across United States, Canada

Drugs / interventions tested

Dalcetrapib (RO4607381) — full drug profile →
Placebo

Conditions studied

Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 75, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percent Change From Baseline in Mean Wall Thickness
Time frame: 24 months
Change From Baseline in Target (Plaque) to Background (Blood) Ratio From an Index Vessel.
Time frame: 6 months

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial.
Fayad ZA, Mani V, Woodward M, Kallend D, et al · · 2011 · cited 396× · PMID 21908036 · DOI 10.1016/s0140-6736(11)61383-4
Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial.
Lüscher TF, Taddei S, Kaski JC, Jukema JW, et al · · 2012 · cited 165× · PMID 22345126 · DOI 10.1093/eurheartj/ehs019
Imaging and nanomedicine in inflammatory atherosclerosis.
Mulder WJ, Jaffer FA, Fayad ZA, Nahrendorf M. · · 2014 · cited 147× · PMID 24898749 · DOI 10.1126/scitranslmed.3005101
A practical method for transforming free-text eligibility criteria into computable criteria.
Tu SW, Peleg M, Carini S, Bobak M, et al · · 2011 · cited 80× · PMID 20851207 · DOI 10.1016/j.jbi.2010.09.007
Relationship of serum inflammatory biomarkers with plaque inflammation assessed by FDG PET/CT: the dal-PLAQUE study.
Duivenvoorden R, Mani V, Woodward M, Kallend D, et al · · 2013 · cited 57× · PMID 24135322 · DOI 10.1016/j.jcmg.2013.03.009
The complementary roles of dynamic contrast-enhanced MRI and 18F-fluorodeoxyglucose PET/CT for imaging of carotid atherosclerosis.
Calcagno C, Ramachandran S, Izquierdo-Garcia D, Mani V, et al · · 2013 · cited 46× · PMID 23942908 · DOI 10.1007/s00259-013-2518-4
Rationale and design of dal-PLAQUE: a study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography.
Fayad ZA, Mani V, Woodward M, Kallend D, et al · · 2011 · cited 41× · PMID 21835280 · DOI 10.1016/j.ahj.2011.05.006
Rationale for cholesteryl ester transfer protein inhibition.
Hewing B, Fisher EA. · · 2012 · cited 38× · PMID 22517614 · DOI 10.1097/mol.0b013e328353ef1d

Verify or expand the search:

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00655473 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 16 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00655473.

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