Coronary Heart DiseasePhase 2NCT00353522

A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.

A Phase 2 study testing dalcetrapib in people with Coronary Heart Disease, run by Hoffmann-La Roche at 17 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
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 17 sitesin 2 countries
Study dates: Jul 2006to Oct 2008
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;
body weight <125kg at visit 1.

Who cannot join

recent (within 3 weeks of screening) clinically significant coronary events;
history of statin-associated myopathy, or intolerance to statin;
history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
exposure to RO4607381 in past 12 months.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States10 sites

Study site
Bethesda, Maryland, 20817
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45212
Study site
Cincinnati, Ohio, 45219
Study site
Indianapolis, Indiana, 46260
Study site
Iowa City, Iowa, 52242
Study site
Louisville, Kentucky, 40213
Study site
Minneapolis, Minnesota, 55455
Study site
Salt Lake City, Utah, 84132
Study site
Statesville, North Carolina, 28677

Other trials in United States

Germany7 sites

Study site
Berlin, 10707
Study site
Bochum, 06097
Study site
Dortmund, 44137
Study site
Erlangen, 91054
Study site
Freiburg im Breisgau, 79106
Study site
Hamburg, 20249
Study site
München, 80336

Other trials in Germany

About this study

Official title: A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 24 weeks
dalcetrapibDrug
900mg po daily for 24 weeks

Study groups in NCT00353522
Study group	Role	What they receive
Dalcetrapib	Experimental	Dalcetrapib 900mg po daily for 24 weeks Receives: Drug: dalcetrapib
Placebo	Placebo comparator	Placebo po daily for 24 weeks Receives: Drug: Placebo

What is being measured

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

Absolute Change From Baseline in HDL-C
Measured: Baseline and Week 24
Percent Change From Baseline in HDL-C
Measured: Baseline and Week 24

Secondary outcomes (4)

Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass
Measured: Baseline and Weeks 24
Change in Mesenteric Lymph Nodes
Measured: Baseline and 48 Weeks
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
Measured: Baseline and 48 Weeks
Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity
Measured: Baseline and 48 Weeks

Timeline

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

Jul 2006Oct 2008

First posted18 Jul 2006 (estimated)
Study startJul 2006
Primary completionOct 2008
Study completionOct 2008

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.
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: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00353522
Sponsor's protocol ID: NC19453
Status last verified: Jan 2020
First submitted: 17 Jul 2006
Last updated: 27 Jan 2020
Results posted: Yes, on ClinicalTrials.gov

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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All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent
ClinicalTrials.gov ID: NCT00353522
Acronym / sponsor ID: NC19453
Conditions: Coronary Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 18 Jul 2006 (estimated)
Results: Posted 27 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	Experimental	Drug: dalcetrapibDalcetrapib 900mg po daily for 24 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo po daily for 24 weeks

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;
body weight <125kg at visit 1.

Key exclusion criteria (4 listed)

recent (within 3 weeks of screening) clinically significant coronary events;
history of statin-associated myopathy, or intolerance to statin;
history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
exposure to RO4607381 in past 12 months.

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 24 weeks	Drug	Placebo
dalcetrapib900mg po daily for 24 weeks	Drug	Dalcetrapib

Primary outcome

Absolute Change From Baseline in HDL-C
Time frame: Baseline and Week 24
Percent Change From Baseline in HDL-C
Time frame: Baseline and Week 24

4 secondary outcomes

Percent Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Mass
Time frame: Baseline and Weeks 24
Change in Mesenteric Lymph Nodes
Time frame: Baseline and 48 Weeks
Change From Baseline in Total Cholesterol (TC), Triglycerides (TG), HDL-C, LDL-C, Apolipoproteins A1 (ApoA1), Apolipoproteins B (ApoB)
Time frame: Baseline and 48 Weeks
Change From Baseline in Cholesterol Ester Transfer Protein (CETP) Activity
Time frame: Baseline and 48 Weeks

Results and safety

Results posted to the registry on 27 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	89	74
Placebo	46	37

Primary outcome: Absolute Change From Baseline in HDL-C

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: mg/dL

Measure	Dalcetrapib n = 89	Placebo n = 45
Value	12.76 (1.17)	0.50 (1.49)

Primary outcome: Percent Change From Baseline in HDL-C

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: Percent Change

Measure	Dalcetrapib n = 89	Placebo n = 45
Value	33.40 (2.86)	3.59 (3.64)

4 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	11 of 89 (12.4%)	0 of 89 (0%)	Not reported
Placebo	6 of 46 (13%)	0 of 46 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Coronary Heart Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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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

17 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 in people with Coronary Heart Disease, run by Hoffmann-La Roche at 17 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 3 inclusion and 4 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 27 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 17 sites in United States, Germany. 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 27 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?

Absolute Change From Baseline in HDL-C (time frame: Baseline and Week 24). 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 NCT00353522.

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 27 Jan 2020.