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HyperlipidemiaPhase 3SUPREMENCT00465088

An Open-Label Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia (SUPREME)

A Phase 3 study testing Niacin ER/Simvastatin Tablets and atorvastatin in people with Hyperlipidemia and Mixed Dyslipidemia, run by Abbott at 46 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

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Hyperlipidemia, Mixed Dyslipidemia
What is being tested?
Niacin ER/Simvastatin Tablets and atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
46 sitesUnited States
Study dates
Apr 2007to Feb 2008
Phase
Phase 3
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following laboratory criteria:
  • HDL-C <40 mg/dL for men and <50 mg/dL for women.
  • LDL-C ≥130 mg/dL but <250 mg/dL.
  • TG <350 mg/dL.
  • Creatine phosphokinase (CPK) < 3 x upper limit of normal (ULN).
  • Alanine aminotransferase (ALT); serum glutamic pyruvic transaminase [SGPT] and aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase [SGOT] < 1.3 x ULN.
  • Subjects must also be reasonably compliant with the Therapeutic Lifestyle Changes (TLC) diet during the 4 to 5 week Screening Period prior to randomization (and be willing to comply for the duration of the study).

Who cannot join

  • Subjects who have a history of any important medical conditions or abnormalities (as specified in the protocol) that would preclude study inclusion

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Study site

    Anaheim, California, 92801

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Auburn, Maine, 04210

  • Study site

    Austin, Texas, 78752

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Boise, Idaho, 83704

  • Study site

    Brooksville, Florida, 34613

  • Study site

    Calhoun, Georgia, 30701

  • Study site

    Canfield, Ohio, 44406

  • Study site

    Carrollton, Texas, 75006

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chicora, Pennsylvania, 16025

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Dallas, Texas, 75251

  • Study site

    Dayton, Ohio, 45458

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Decatur, Georgia, 30034

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Gig Harbor, Washington, 98335

  • Study site

    Harleysville, Pennsylvania, 19438

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Houston, Texas, 77074

  • Study site

    Huntington Park, California, 90255

  • Study site

    Largo, Florida, 33770

  • Study site

    Long Beach, California, 90822

  • Study site

    Magna, Utah, 84044

  • Study site

    Menomonee Falls, Wisconsin, 53051

  • Study site

    Merritt Island, Florida, 32953

  • Study site

    Miami, Florida, 33126

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Missoula, Montana, 59808

  • Study site

    Newton, Kansas, 67114

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Protland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Sacramento, California, 95825

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78224

  • Study site

    Shawnee Mission, Kansas, 66216

  • Study site

    Topeka, Kansas, 55508

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Wichita, Kansas, 67203

Other trials in United States

About this study

Official title: SUPREME: A 12-Week, Open-Label, Multicenter Study to Compare the Lipid Effects of Niacin ER and Simvastatin (NS) to Atorvastatin in Subjects With Hyperlipidemia or Mixed Dyslipidemia

To demonstrate that niacin ER and simvastatin (NS) tablets, when compared to atorvastatin (Lipitor®; Pfizer, Inc.), has superior high-density lipoprotein cholesterol (HDL-C) elevating effects at Week 12 in subjects with type II hyperlipidemia or mixed dyslipidemia who are currently off lipid-modifying therapy. This was a prospective, randomized, open-label, blinded endpoint (PROBE) study.

Being tested
Niacin ER/Simvastatin Tablets, atorvastatin
Medical subject headings
Hyperlipidemias

What participants receive

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

  • Niacin ER/Simvastatin TabletsDrug

    Also called ABT-919/483, Niacin ER/Simvastatin, Simcor

    Up to 2000 mg/40 mg at bedtime

  • atorvastatinDrug

    40 mg at bedtime

Study groups in NCT00465088
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Niacin ER/Simvastatin Tablets
2ExperimentalNot described
Receives: Drug: atorvastatin

What is being measured

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

  1. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12

    (Week 12 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

    Measured: From baseline to Week 12

Secondary outcomes (13)

  1. Percent Change in HDL-C From Baseline to Week 8

    (Week 8 HDL-C minus baseline HDL-C) x 100/baseline HDL-C

    Measured: From baseline to Week 8

  2. Percent Change in Non-HDL-C From Baseline to Week 8

    (Week 8 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

    Measured: From baseline to Week 8

  3. Percent Change in Non-HDL-C From Baseline to Week 12

    (Week 12 non-HDL-C minus baseline non-HDL-C) x 100/baseline non-HDL-C

    Measured: From baseline to Week 12

  4. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12

    (Week 12 LDL-C minus baseline LDL-C) x 100/baseline LDL-C

    Measured: From baseline to Week 12

  5. Percent Change in Triglycerides From Baseline to Week 12

    (Week 12 triglycerides minus baseline triglycerides) x 100/baseline triglycerides

    Measured: From baseline to Week 12

  6. Percent Change in LDL-C:HDL-C Ratio

    (Week 12 LDL-C:HDL-C ratio minus baseline LDL-C:HDL-C ratio) x 100/baseline LDL-C:HDL-C ratio

    Measured: From baseline to Week 12

  7. Percent Change in Total Cholesterol From Baseline to Week 12

    (Week 12 total cholesterol minus baseline total cholesterol) x 100/baseline total cholesterol

    Measured: From baseline to Week 12

  8. Percent Change in Total Cholesterol:HDL-C Ratio

    (Week 12 total cholesterol:HDL-C ratio minus baseline total cholesterol:HDL-C ratio) x 100/baseline total cholesterol:HDL-C ratio

    Measured: From baseline to Week 12

  9. Percent Change in Lipoprotein A From Baseline to Week 12

    (Week 12 lipoprotein A minus baseline lipoprotein A) x 100/baseline lipoprotein A

    Measured: From baseline to Week 12

  10. Percentage of Subjects Meeting With HDL-C >/= 40 mg/dL at Week 12

    Measured: 12 weeks

  11. Percentage of Subjects Meeting National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Goal for LDL-C at Week 12

    For high-risk patients (coronary heart disease or equivalent), LDL-C < 100 mg/dL and non-HDL-C < 130 mg/dL; for moderate risk patients (having 2 risk factors), LDL-C < 130 mg/dL and non-HDL-C < 160 mg/dL; for low-risk patients (having 0 or 1 risk factor): LDL-C < 160 mg/dL and non-HDL-C < 190 mg/dL.

    Measured: 12 weeks

  12. Percentage of Subjects With Triglycerides < 150 mg/dL at Week 12

    Measured: 12 weeks

  13. Percentage of Subjects With HDL-C >/= 40 mg/dL, LDL-C Meeting NCEP ATP III Goal, and Triglycerides < 150 mg/dL at Week 12

    NCEP ATP III goals for LDL-C are as follows: For high-risk patients, LDL-C < 100 mg/dL; for moderate risk patients, LDL-C < 130 mg/dL; for low-risk patients: LDL-C < 160 mg/dL. High-risk means coronary heart disease or risk equivalents; moderate risk means having at least 2 risk factors; low-risk means having no or 1 risk factor.

    Measured: 12 weeks

Timeline

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

  1. First posted24 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionFeb 2008

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00465088
Sponsor's protocol ID
019-05-06-CR
Other IDs
M10-013
Acronym
SUPREME
Status last verified
Jun 2011
First submitted
23 Apr 2007
Last updated
13 Jun 2011

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niacin ER/Simvastatin Tablets and atorvastatin in people with Hyperlipidemia and Mixed Dyslipidemia, run by Abbott at 46 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 7 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 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 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. 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 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?

Yes. Results are posted in the registry (first posted 13 May 2009). 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 in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 12 (time frame: From baseline to Week 12). 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 NCT00465088.

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 13 Jun 2011.

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