Coronary Heart DiseasePhase 2NCT00400439

A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381

A Phase 2 study testing dalcetrapib (RO4607381) in people with Coronary Heart Disease, run by Hoffmann-La Roche at 9 sites in United States.

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: 77 participants
Where: 9 sitesUnited States
Study dates: Jan 2007to Jan 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

patients who have completed treatment on study NC19453.

Who cannot join

any significant lymph node abnormalities at the end of study NC19453.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Study site
Bethesda, Maryland, 20817
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

About this study

Official title: A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 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
900mg po daily for 24 weeks
placeboDrug
po daily for 24 weeks

Study groups in NCT00400439
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 HDL-C
Measured: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))

Secondary outcomes (1)

Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Measured: Baseline and Week 24 (Week 48 from start of NC19453)

Timeline

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

Jan 2007Jan 2008

First posted16 Nov 2006 (estimated)
Study startJan 2007
Primary completionJan 2008
Study completionJan 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: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00400439
Sponsor's protocol ID: NC20716
Status last verified: Dec 2019
First submitted: 15 Nov 2006
Last updated: 3 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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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 Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381
ClinicalTrials.gov ID: NCT00400439
Acronym / sponsor ID: NC20716
Conditions: Coronary Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 16 Nov 2006 (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 (1 listed)

patients who have completed treatment on study NC19453.

Key exclusion criteria (1 listed)

any significant lymph node abnormalities at the end of study NC19453.

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)900mg po daily for 24 weeks	Drug	dalcetrapib (RO4607381)
placebopo daily for 24 weeks	Drug	placebo

Primary outcome

Percent Change From Baseline in HDL-C
Time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))

1 secondary outcome

Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Apolipoprotein B (ApoB) and Apolipoprotein A1 (ApoA1)
Time frame: Baseline and Week 24 (Week 48 from start of NC19453)

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)	52	47
Placebo	25	23

Primary outcome: Percent Change From Baseline in HDL-C

Time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522)). Least squares mean (Standard Error). Unit: Percentage Change of HDL-C

Measure	Dalcetrapib (RO4607381) n = 52	Placebo n = 25
Value	33.76 (4.43)	3.69 (5.81)

1 secondary outcome is 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)	0 of 0	0 of 0	Not reported
Placebo	0 of 0	0 of 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.

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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

9 sites in 1 country: 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 9 sites in United States.

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 1 inclusion and 1 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 9 sites in United States. 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 HDL-C (time frame: Baseline and Week 24 (Week 48 from start of NC19453(NCT00353522))). 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 NCT00400439.

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.