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DyslipidemiaPhase 2/3NCT00245388

Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

A Phase 2/3 study testing Muraglitazar in people with Dyslipidemia, run by Bristol-Myers Squibb at 54 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

This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dyslipidemia
What is being tested?
Muraglitazar
How many people
330 participants
Where
54 sitesin 2 countries
Study dates
Apr 2002to Jul 2002
Phase
Phase 2/3
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-diabetics
  • Serum TG >150 mg/dL and < or = 600 mg/dL
  • Serum LDL-C >130 mg/dL

Who cannot join

  • Type 1 or type 2 diabetics
  • Fasting plasma glucose >126 mg/dL
  • Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):
  • Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks
  • Fibrates: 8 weeks
  • Probucol: 1 year
  • History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States53 sites

  • Local Institution

    Austin, Texas

  • Local Institution

    Baltimore, Maryland

  • Local Institution

    Bend, Oregon

  • Local Institution

    Bethesda, Maryland

  • Local Institution

    Clearwater, Florida

  • Local Institution

    Columbus, Ohio

  • Local Institution

    Cooper City, Florida

  • Local Institution

    Dallas, Texas

  • Local Institution

    DeLand, Florida

  • Local Institution

    Dunwoody, Georgia

  • Local Institution

    Edina, Minnesota

  • Local Institution

    Greer, South Carolina

  • Local Institution

    Hickory, North Carolina

  • Local Institution

    Hillsboro, Oregon

  • Local Institution

    Indianapolis, Indiana

  • Local Institution

    Inverness, Florida

  • Local Institution

    Iowa City, Iowa

  • Local Institution

    Irvine, California

  • Local Institution

    Kansas City, Missouri

  • Local Institution

    Little Rock, Arkansas

  • Local Institution

    Long Beach, California

  • Local Institution

    Longmont, Colorado

  • Local Institution

    Longwood, Florida

  • Local Institution

    Louisville, Kentucky

  • Local Institution

    Manlius, New York

  • Local Institution

    Marrero, Louisiana

  • Local Institution

    Melbourne, Georgia

  • Local Institution

    Minneapolis, Minnesota

  • Local Institution

    Mt. Pleasant, South Carolina

  • Local Institution

    Olympia, Washington

  • Local Institution

    Overland Park, Kansas

  • Local Institution

    Pembroke Pines, Florida

  • Local Institution

    Peoria, Illinois

  • Local Institution

    Philadelphia, Pennsylvania

  • Local Institution

    Phoenix, Arizona

  • Local Institution

    Portland, Oregon

  • Local Institution

    Raleigh, California

  • Local Institution

    Roseville, California

  • Local Institution

    Sacramento, California

  • Local Institution

    San Angelo, Texas

  • Local Institution

    San Antonio, Texas

  • Local Institution

    San Diego, California

  • Local Institution

    Santa Ana, California

  • Local Institution

    Sarasota, Florida

  • Local Institution

    Seattle, Washington

  • Local Institution

    Sellersville, Pennsylvania

  • Local Institution

    St Louis, Missouri

  • Local Institution

    Stuart, Florida

  • Local Institution

    Toms River, New Jersey

  • Local Institution

    Warminster, Pennsylvania

  • Local Institution

    Wichita, Kansas

  • Local Institution

    Winston-Salem, North Carolina

  • Local Institution

    Yakima, Washington

Other trials in United States

Canada1 site

  • Local Institution

    Ottawa, Ontario

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia

This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.

Conditions
Dyslipidemia
Being tested
Muraglitazar
Keywords
Mixed Dyslipidemia
Medical subject headings
Dyslipidemias

What participants receive

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

  • MuraglitazarDrug

What is being measured

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

  1. To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg

Secondary outcomes (1)

  1. Percent changes from baseline to average at week 5-6 of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoprotein A1 (ApoA1), and free fatty acid (FFA) levels

Timeline

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

  1. First posted28 Oct 2005 (estimated)
  2. Study startApr 2002
  3. Study completionJul 2002

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
330 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00245388
Sponsor's protocol ID
CV168-008
Status last verified
Apr 2012
First submitted
14 Oct 2005
Last updated
23 Apr 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Muraglitazar in people with Dyslipidemia, run by Bristol-Myers Squibb at 54 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 7 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg. 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 NCT00245388.

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 23 Apr 2012.

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