Coronary Heart DiseasePhase 2NCT00655473

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

A Phase 2 study testing Dalcetrapib (RO4607381) in people with Coronary Heart Disease, run by Hoffmann-La Roche at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: Dalcetrapib (RO4607381)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 12 sitesin 2 countries
Study dates: Mar 2008to Nov 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients, 18-75 years of age;
CHD, including patients with other CHD risk factors;
treated appropriately for dyslipidemia;
clinically stable.

Who cannot join

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.

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States11 sites

Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Cleveland, Ohio, 44195
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32216
Study site
Kansas City, Missouri, 64111
Study site
Minneapolis, Minnesota, 55455
Study site
New York, New York, 10029
Study site
Royal Oak, Michigan, 48073
Study site
Seattle, Washington, 98108
Study site
Statesville, North Carolina, 28677

Other trials in United States

Canada1 site

Study site
Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: 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

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.

Conditions: Coronary Heart Disease
Being tested: Dalcetrapib (RO4607381), Placebo
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dalcetrapib (RO4607381)Drug
600mg po daily for 24 months
PlaceboDrug
po daily for 24 months

Study groups in NCT00655473
Study group	Role	What they receive
Dalcetrapib (RO4607381)	Experimental	Not described Receives: Drug: Dalcetrapib (RO4607381)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Measured: 6 months
Change From Baseline in Vessel MR Determined Plaque Anatomy
Measured: Up to 24 months
Blood Lipids,Lipoproteins
Measured: Throughout study
Biomarkers
Measured: Up to 24 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Nov 2010

First posted10 Apr 2008 (estimated)
Study startMar 2008
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00655473
Sponsor's protocol ID: NC21153
Status last verified: Dec 2019
First submitted: 28 Mar 2008
Last updated: 3 Jan 2020
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00655473
Acronym / sponsor ID: NC21153
Conditions: Coronary Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 10 Apr 2008 (estimated)
Results: Posted 3 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dalcetrapib (RO4607381)	Experimental	Drug: Dalcetrapib (RO4607381)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

adult patients, 18-75 years of age;
CHD, including patients with other CHD risk factors;
treated appropriately for dyslipidemia;
clinically stable.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dalcetrapib (RO4607381)600mg po daily for 24 months	Drug	Dalcetrapib (RO4607381)
Placebopo daily for 24 months	Drug	Placebo

Primary outcome

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

5 secondary outcomes

Change From Baseline in Vessel Magnetic Resonance (MR) Determined Compliance
Time frame: 6 months
Change From Baseline in Vessel MR Determined Plaque Anatomy
Time frame: Up to 24 months
Blood Lipids,Lipoproteins
Time frame: Throughout study
Biomarkers
Time frame: Up to 24 months
CHD, Major Coronary Events, Adverse Events (AEs), Lab Parameters, Blood Pressure
Time frame: Throughout study

Results and safety

Results posted to the registry on 3 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalcetrapib (RO4607381)	64	53
Placebo	66	51

Primary outcome: Percent Change From Baseline in Mean Wall Thickness

Time frame: 24 months. Least squares mean (Standard Error). Unit: Percent Change

Measure	Dalcetrapib (RO4607381) n = 64	Placebo n = 66
Value	4.245 (3.018)	6.679 (3.111)

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

Time frame: 6 months. Least squares mean (Standard Error). Unit: Ratio

Measure	Dalcetrapib (RO4607381) n = 64	Placebo n = 66
Value	-0.188 (0.078)	-0.260 (0.079)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalcetrapib (RO4607381)	20 of 64 (31.3%)	0 of 64 (0%)	Not reported
Placebo	19 of 66 (28.8%)	0 of 66 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24135322Duivenvoorden 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.
Derived from this study: PubMed 23942908Calcagno 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.
Derived from this study: PubMed 21908036Fayad 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalcetrapib (RO4607381) in people with Coronary Heart Disease, run by Hoffmann-La Roche at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Mean Wall Thickness (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655473, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.