DyslipidemiaPhase 2NCT00697203

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

A Phase 2 study testing Pravastatin and Dalcetrapib in people with Dyslipidemia, run by Hoffmann-La Roche at 33 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

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dyslipidemia
What is being tested?: Pravastatin and Dalcetrapib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 292 participants
Where: 33 sitesUnited States
Study dates: Jul 2005to May 2006
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;
dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Who cannot join

women who are pregnant, breastfeeding, or of child-bearing potential;
morbid obesity;
uncontrolled hypertension;
poorly controlled or insulin-treated diabetes;
high creatinine levels or history of statin-associated myopathy.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

United States33 sites

Study site
Auburn, Maine, 04210
Study site
Baltimore, Maryland, 21201
Study site
Bethesda, Maryland, 20817
Study site
Chalmette, Louisiana, 70043
Study site
Charlotte, North Carolina, 28209
Study site
Chicago, Illinois, 60610-4319
Study site
Cincinnati, Ohio, 45212
Study site
Concord, New Hampshire, 03301
Study site
Evansville, Indiana, 47714
Study site
Fort Worth, Texas, 76107
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46260
Study site
Iowa City, Iowa, 52242
Study site
Louisville, Kentucky, 40213
Study site
Madison, Wisconsin, 53719
Study site
Miami, Florida, 33137
Study site
Mobile, Alabama, 36608
Study site
Newark, Delaware, 19713
Study site
Oklahoma City, Oklahoma, 73103
Study site
Overland Park, Kansas, 66215
Study site
Philadelphia, Pennsylvania, 19107
Study site
Richmond, Virginia, 23294
Study site
Scarborough, Maine, 04074
Study site
Scottsdale, Arizona, 85251
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Seattle, Washington, 98104
Study site
Slidell, Louisiana, 70458
Study site
Springdale, Ohio, 45246
Study site
St Louis, Missouri, 63110
Study site
Statesville, North Carolina, 28677
Study site
Towson, Maryland, 21204
Study site
Warminster, Pennsylvania, 18974
Study site
Wichita, Kansas, 67207
Study site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

Conditions: Dyslipidemia
Being tested: Placebo, Pravastatin, Dalcetrapib
Medical subject headings: Dyslipidemias

What participants receive

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

PlaceboDrug
po daily for 12 weeks
PravastatinDrug
40mg po daily for 12 weeks
DalcetrapibDrug
300mg po daily for 12 weeks
DalcetrapibDrug
600mg po daily for 12 weeks
DalcetrapibDrug
900mg po daily for 12 weeks

Study groups in NCT00697203
Study group	Role	What they receive
Dalcetrapib 300mg	Experimental	Not described Receives: Drug: Pravastatin; Drug: Dalcetrapib
Dalcetrapib 600mg	Experimental	Not described Receives: Drug: Pravastatin; Drug: Dalcetrapib
Dalcetrapib 900mg	Experimental	Not described Receives: Drug: Pravastatin; Drug: Dalcetrapib
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Drug: Pravastatin

What is being measured

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

Absolute Change From Baseline in HDL-C Level\n
Measured: Week 12
Percent Change From Baseline in HDL-C Level\n
Measured: 12 Weeks

Secondary outcomes (4)

Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Measured: 12 weeks
Percent Change of Fasting Glucose Level
Measured: 12 weeks
AEs, Lab Parameters, Vital Signs, ECG
Measured: Through 9 Months
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
Measured: Baseline and at 12 Weeks

Timeline

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

Jul 2005May 2006

First posted13 Jun 2008 (estimated)
Study startJul 2005
Primary completionMay 2006
Study completionMay 2006

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 DyslipidemiaStudies 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: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00697203
Sponsor's protocol ID: NC18589
Status last verified: Dec 2019
First submitted: 11 Jun 2008
Last updated: 2 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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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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All Dyslipidemia trials

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, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels
ClinicalTrials.gov ID: NCT00697203
Acronym / sponsor ID: NC18589
Conditions: Dyslipidemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 13 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Dalcetrapib 300mg	Experimental	Drug: Pravastatin, Drug: Dalcetrapib
Dalcetrapib 600mg	Experimental	Drug: Pravastatin, Drug: Dalcetrapib
Dalcetrapib 900mg	Experimental	Drug: Pravastatin, Drug: Dalcetrapib
Placebo	Placebo comparator	Drug: Placebo, Drug: Pravastatin

Who may qualify

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

Key inclusion criteria (2 listed)

adult patients 18-75 years of age;
dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

Key exclusion criteria (5 listed)

women who are pregnant, breastfeeding, or of child-bearing potential;
morbid obesity;
uncontrolled hypertension;
poorly controlled or insulin-treated diabetes;
high creatinine levels or history of statin-associated myopathy.

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 12 weeks	Drug	Placebo
Pravastatin40mg po daily for 12 weeks	Drug	Dalcetrapib 300mg, Dalcetrapib 600mg, Dalcetrapib 900mg, Placebo
Dalcetrapib300mg po daily for 12 weeks	Drug	Dalcetrapib 300mg
Dalcetrapib600mg po daily for 12 weeks	Drug	Dalcetrapib 600mg
Dalcetrapib900mg po daily for 12 weeks	Drug	Dalcetrapib 900mg

Primary outcome

Absolute Change From Baseline in HDL-C Level\n
Time frame: Week 12
Percent Change From Baseline in HDL-C Level\n
Time frame: 12 Weeks

4 secondary outcomes

Change From Baseline in: Total Cholesterol, Triglycerides, HDL-C, LDL-C, HDL-2, HDL-3, ApoA1, ApoA2, ApoB, LpAI
Time frame: 12 weeks
Percent Change of Fasting Glucose Level
Time frame: 12 weeks
AEs, Lab Parameters, Vital Signs, ECG
Time frame: Through 9 Months
Ratios of Total HDL-C/LDL-C, HDL-2/HDL-3, ApoA1/ApoB
Time frame: Baseline and at 12 Weeks

Results and safety

Results posted to the registry on 2 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 300mg	76	67
Dalcetrapib 600mg	68	62
Dalcetrapib 900mg	74	66
Placebo	74	67

Primary outcome: Absolute Change From Baseline in HDL-C Level\n

Time frame: Week 12. Least squares mean (Standard Error). Unit: mg/dL

Measure	Dalcetrapib 300mg n = 75	Dalcetrapib 600mg n = 67	Dalcetrapib 900mg n = 72	Placebo n = 73
Value	17.18 (2.19)	31.42 (2.29)	36.45 (2.24)	2.31 (2.18)

Primary outcome: Percent Change From Baseline in HDL-C Level\n

Time frame: 12 Weeks. Least squares mean (Standard Error). Unit: Percent change in mg/dL

Measure	Dalcetrapib 300mg n = 75	Dalcetrapib 600mg n = 67	Dalcetrapib 900mg n = 72	Placebo n = 73
Value	6.58 (0.84)	11.90 (0.88)	13.92 (0.86)	0.73 (0.84)

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 300mg	2 of 76 (2.6%)	0 of 76 (0%)	Not reported
Dalcetrapib 600mg	2 of 68 (2.9%)	0 of 68 (0%)	Not reported
Dalcetrapib 900mg	3 of 74 (4.1%)	0 of 74 (0%)	Not reported
Placebo	2 of 74 (2.7%)	0 of 74 (0%)	Not reported

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.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

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

33 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 Pravastatin and Dalcetrapib in people with Dyslipidemia, run by Hoffmann-La Roche at 33 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 2 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 33 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 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?

Absolute Change From Baseline in HDL-C Level\n (time frame: Week 12). 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 NCT00697203.

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.