Coronary Heart DiseasePhase 2NCT00655538
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 study testing dalcetrapib in people with Coronary Heart Disease, run by Hoffmann-La Roche at 23 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- dalcetrapib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Feb 2008to May 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 or CHD risk equivalent;
- appropriately treated for accepted LDL-C level.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Netherlands12 sites
Study site
Amsterdam, 1105 AZ
Study site
Breda, 4811 SW
Study site
Eindhoven, 5611 NJ
Study site
Goes, 4462 RA
Study site
Groningen, 9711 SG
Study site
Hoorn, 1625 HV
Study site
Leiderdorp, 2352 RA
Study site
Nijmegen, 6525 EC
Study site
Rotterdam, 3021 HC
Study site
Utrecht, 3508 GA
Study site
Velp, 6883 ES
Study site
Zoetermeer, 2724 EK
Germany5 sites
Study site
Bonn, 53127
Study site
Dortmund, 44137
Study site
Frankfurt, 60596
Study site
Mainz, 55131
Study site
Wuppertal, 42117
About this study
Official title: A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.
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.
- Conditions
- Coronary Heart Disease
- Being tested
- Placebo, dalcetrapib
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po daily for 36 weeks
dalcetrapibDrug
600mg po daily for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dalcetrapib | Experimental | Not described Receives: Drug: dalcetrapib |
| 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.
Change From Baseline in % Flow Mediated Dilatation (FMD)
Measured: Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Measured: Baseline and 4 weeks
Secondary outcomes (6)
Change From Baseline in % FMD
Measured: baseline and 36 weeks
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Measured: Baseline to 36 weeks
CETP Activity
Measured: Up to 36 weeks
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
Measured: Baseline and 36 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Measured: Up to 36 weeks
Percent Change CETP Mass
Measured: baseline to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionMay 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 (2)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
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655538
- Sponsor's protocol ID
- BC21144
- Other IDs
- 2007-003406-10
- Status last verified
- Dec 2019
- First submitted
- 28 Mar 2008
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
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 22345126Kastelein 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.
- ClinicalTrials.gov ID
- NCT00655538
- Acronym / sponsor ID
- BC21144
- Conditions
- Coronary Heart Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalcetrapib | Experimental | Drug: dalcetrapib |
| 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 (3 listed)
- adult patients, 18-75 years of age;
- CHD or CHD risk equivalent;
- appropriately treated for accepted LDL-C level.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Placebopo daily for 36 weeks | Drug | Placebo |
| dalcetrapib600mg po daily for 36 weeks | Drug | Dalcetrapib |
Primary outcome
Change From Baseline in % Flow Mediated Dilatation (FMD)
Time frame: Baseline and 12 weeks
Change From Baseline in Mean BP, Measured by BP Monitoring
Time frame: Baseline and 4 weeks
6 secondary outcomes
Change From Baseline in % FMD
Time frame: baseline and 36 weeks
Percent Change in HDL-C, LDL-C, Total Cholesterol, Triglycerides, ApoA1, ApoB
Time frame: Baseline to 36 weeks
CETP Activity
Time frame: Up to 36 weeks
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
Change From Baseline in Mean BP, Measured by BP Monitoring
Time frame: Up to 36 weeks
Percent Change CETP Mass
Time frame: baseline to 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22345126Luscher 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.
- Derived from this study: PubMed 21128879Kastelein 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.
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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
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dalcetrapib in people with Coronary Heart Disease, run by Hoffmann-La Roche at 23 sites in 7 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 3 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 2 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 23 sites in Netherlands, Germany, Switzerland, Austria, France and 2 more countries. 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 2 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?
Change From Baseline in % Flow Mediated Dilatation (FMD) (time frame: Baseline and 12 weeks). 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 NCT00655538, which also lists 2 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 2 Jan 2020.