Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

September 27, 2012 updated by: AstraZeneca

An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
474

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Site Reference ID/Investigator# 12654
      • Columbiana, Alabama, United States, 35051
        • Site Reference ID/Investigator# 12634
      • Huntsville, Alabama, United States, 35801
        • Site Reference ID/Investigator# 12559
      • Ozark, Alabama, United States, 36360
        • Site Reference ID/Investigator# 12499
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Site Reference ID/Investigator# 12673
      • Scottsdale, Arizona, United States, 85251
        • Site Reference ID/Investigator# 17282
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Site Reference ID/Investigator# 12657
    • California
      • Anaheim, California, United States, 92804
        • Site Reference ID/Investigator# 12489
      • Carmichael, California, United States, 95608
        • Site Reference ID/Investigator# 12495
      • Chula Vista, California, United States, 91911
        • Site Reference ID/Investigator# 12467
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 12498
      • Los Angeles, California, United States, 90057
        • Site Reference ID/Investigator# 12602
      • Norwalk, California, United States, 90650
        • Site Reference ID/Investigator# 12510
      • Palm Desert, California, United States, 92260
        • Site Reference ID/Investigator# 12550
      • Roseville, California, United States, 95661
        • Site Reference ID/Investigator# 16503
      • Sacramento, California, United States, 95825
        • Site Reference ID/Investigator# 12678
      • Sacramento, California, United States, 95825
        • Site Reference ID/Investigator# 14241
      • San Diego, California, United States, 92123
        • Site Reference ID/Investigator# 12473
      • Walnut Creek, California, United States, 94598
        • Site Reference ID/Investigator# 12497
      • West Hills, California, United States, 91307
        • Site Reference ID/Investigator# 12680
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Site Reference ID/Investigator# 12461
      • Colorado Springs, Colorado, United States, 80909
        • Site Reference ID/Investigator# 12600
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Site Reference ID/Investigator# 12679
    • Florida
      • Clearwater, Florida, United States, 33756
        • Site Reference ID/Investigator# 12598
      • Coral Gables, Florida, United States, 33134
        • Site Reference ID/Investigator# 15542
      • Daytona Beach, Florida, United States, 32117
        • Site Reference ID/Investigator# 12477
      • Delray Beach, Florida, United States, 33484
        • Site Reference ID/Investigator# 12668
      • Fort Lauderdale, Florida, United States, 33306
        • Site Reference ID/Investigator# 15483
      • Fort Myers, Florida, United States, 33907
        • Site Reference ID/Investigator# 12645
      • Hollywood, Florida, United States, 33023
        • Site Reference ID/Investigator# 12672
      • Jacksonville, Florida, United States, 32205
        • Site Reference ID/Investigator# 17504
      • Jacksonville, Florida, United States, 32259
        • Site Reference ID/Investigator# 12781
      • Jupiter, Florida, United States, 33458-7200
        • Site Reference ID/Investigator# 12665
      • Longwood, Florida, United States, 32779
        • Site Reference ID/Investigator# 12682
      • Melbourne, Florida, United States, 32935
        • Site Reference ID/Investigator# 15486
      • New Port Richey, Florida, United States, 34652
        • Site Reference ID/Investigator# 12502
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 12647
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 12520
      • Ormond Beach, Florida, United States, 32174
        • Site Reference ID/Investigator# 12687
      • Sarasota, Florida, United States, 34233
        • Site Reference ID/Investigator# 12583
      • Tampa, Florida, United States, 33607
        • Site Reference ID/Investigator# 12652
      • West Palm Beach, Florida, United States, 33401
        • Site Reference ID/Investigator# 12557
      • Winter Haven, Florida, United States, 33880
        • Site Reference ID/Investigator# 12621
      • Winter Park, Florida, United States, 32792
        • Site Reference ID/Investigator# 16505
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Site Reference ID/Investigator# 12675
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 12620
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 12653
      • Suwanee, Georgia, United States, 30024
        • Site Reference ID/Investigator# 12555
      • Woodstock, Georgia, United States, 30189
        • Site Reference ID/Investigator# 12787
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Site Reference ID/Investigator# 12514
      • Peoria, Illinois, United States, 61602
        • Site Reference ID/Investigator# 12487
      • Peoria, Illinois, United States, 61614
        • Site Reference ID/Investigator# 12627
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site Reference ID/Investigator# 12529
      • Indianapolis, Indiana, United States, 46260
        • Site Reference ID/Investigator# 12688
      • South Bend, Indiana, United States, 46601
        • Site Reference ID/Investigator# 15485
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Site Reference ID/Investigator# 12676
      • Wichita, Kansas, United States, 67203
        • Site Reference ID/Investigator# 12597
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Site Reference ID/Investigator# 12472
      • Mount Sterling, Kentucky, United States, 40353
        • Site Reference ID/Investigator# 12658
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Site Reference ID/Investigator# 12586
      • Bethesda, Maryland, United States, 20817
        • Site Reference ID/Investigator# 12480
      • Oxon Hill, Maryland, United States, 20745
        • Site Reference ID/Investigator# 12638
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Site Reference ID/Investigator# 12513
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Site Reference ID/Investigator# 12663
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Site Reference ID/Investigator# 12609
      • Edina, Minnesota, United States, 55435
        • Site Reference ID/Investigator# 16622
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site Reference ID/Investigator# 12625
      • Olive Branch, Mississippi, United States, 38654
        • Site Reference ID/Investigator# 12560
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 12677
      • St. Peters, Missouri, United States, 63376
        • Site Reference ID/Investigator# 12534
    • Montana
      • Billings, Montana, United States, 59101
        • Site Reference ID/Investigator# 12592
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 12655
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Site Reference ID/Investigator# 12587
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Site Reference ID/Investigator# 12554
      • Elizabeth, New Jersey, United States, 07202
        • Site Reference ID/Investigator# 12637
      • Hillsborough, New Jersey, United States, 08844
        • Site Reference ID/Investigator# 12463
      • Trenton, New Jersey, United States, 08611
        • Site Reference ID/Investigator# 12660
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Site Reference ID/Investigator# 12506
    • New York
      • Johnson City, New York, United States, 13790
        • Site Reference ID/Investigator# 12539
      • Syracuse, New York, United States, 13202
        • Site Reference ID/Investigator# 12631
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Site Reference ID/Investigator# 17503
      • Charlotte, North Carolina, United States, 28209
        • Site Reference ID/Investigator# 12650
      • Charlotte, North Carolina, United States, 28211
        • Site Reference ID/Investigator# 12504
      • Charlotte, North Carolina, United States, 28262
        • Site Reference ID/Investigator# 12558
      • Charlotte, North Carolina, United States, 28277
        • Site Reference ID/Investigator# 12671
      • Hickory, North Carolina, United States, 28601
        • Site Reference ID/Investigator# 12527
      • Morehead City, North Carolina, United States, 28557
        • Site Reference ID/Investigator# 12608
      • Salisbury, North Carolina, United States, 28144
        • Site Reference ID/Investigator# 12535
      • Statesville, North Carolina, United States, 28677
        • Site Reference ID/Investigator# 12656
      • Wilmington, North Carolina, United States, 28401
        • Site Reference ID/Investigator# 17641
      • Winston-Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 12606
    • Ohio
      • Akron, Ohio, United States, 44311
        • Site Reference ID/Investigator# 12614
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 12662
      • Cincinnati, Ohio, United States, 45242
        • Site Reference ID/Investigator# 12545
      • Kettering, Ohio, United States, 45429
        • Site Reference ID/Investigator# 12640
      • Mason, Ohio, United States, 45040
        • Site Reference ID/Investigator# 12786
      • Warren, Ohio, United States, 44483
        • Site Reference ID/Investigator# 12630
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Site Reference ID/Investigator# 12551
      • Tulsa, Oklahoma, United States, 74136
        • Site Reference ID/Investigator# 12611
    • Oregon
      • Medford, Oregon, United States, 97504
        • Site Reference ID/Investigator# 12585
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Site Reference ID/Investigator# 12610
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 12589
      • Harleysville, Pennsylvania, United States, 19438-2513
        • Site Reference ID/Investigator# 12607
      • Jersey Shore, Pennsylvania, United States, 17740
        • Site Reference ID/Investigator# 12641
      • Melrose Park, Pennsylvania, United States, 19027
        • Site Reference ID/Investigator# 12507
      • Perkasie, Pennsylvania, United States, 18944
        • Site Reference ID/Investigator# 12624
      • Philadelphia, Pennsylvania, United States, 19114
        • Site Reference ID/Investigator# 12669
      • Philadelphia, Pennsylvania, United States, 19152
        • Site Reference ID/Investigator# 12788
      • Pittsburgh, Pennsylvania, United States, 15216
        • Site Reference ID/Investigator# 12525
      • Tipton, Pennsylvania, United States, 16684
        • Site Reference ID/Investigator# 12601
      • Warminster, Pennsylvania, United States, 18974
        • Site Reference ID/Investigator# 12686
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Site Reference ID/Investigator# 12623
      • Mount Pleasant, South Carolina, United States, 29464
        • Site Reference ID/Investigator# 12681
      • Simpsonville, South Carolina, United States, 29681
        • Site Reference ID/Investigator# 12485
      • Summerville, South Carolina, United States, 29485
        • Site Reference ID/Investigator# 12639
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Site Reference ID/Investigator# 15642
      • Jackson, Tennessee, United States, 38305
        • Site Reference ID/Investigator# 12643
    • Texas
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 12470
      • Dallas, Texas, United States, 75234
        • Site Reference ID/Investigator# 16081
      • Dallas, Texas, United States, 75251
        • Site Reference ID/Investigator# 12492
      • Fort Worth, Texas, United States, 76104
        • Site Reference ID/Investigator# 12464
      • San Antonio, Texas, United States, 78205
        • Site Reference ID/Investigator# 12646
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 16601
      • San Antonio, Texas, United States, 78224
        • Site Reference ID/Investigator# 12540
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 12466
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 12622
    • Virginia
      • Norfolk, Virginia, United States, 23502-9921
        • Site Reference ID/Investigator# 12538
      • Richmond, Virginia, United States, 23294
        • Site Reference ID/Investigator# 12616
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • Site Reference ID/Investigator# 12476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Participants with hypercholesterolemia and hypertriglyceridemia.

  • Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):

    • Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
    • Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.

Exclusion Criteria

  • Participants with certain chronic or unstable medical conditions.
  • Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
  • Pregnant or lactating women, or women intending to become pregnant.
  • Participants with diabetes mellitus that is poorly controlled.
  • Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A - ABT-143 capsules 5/135 mg
ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Experimental: B - ABT-143 capsules 10/135 mg
ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Experimental: C - ABT-143 capsules 20/135 mg
ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Active Comparator: D - Simvastatin capsules 40 mg
Simvastatin capsules 40 mg daily for 8 weeks
Drug: simvastatin
Once daily for 8 weeks simvastatin capsules 40 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Time Frame: Baseline to 8 weeks

The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:

ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)
Time Frame: Baseline to 8 weeks
The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Baseline to 8 weeks
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)
Time Frame: Baseline to 8 weeks
The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
Baseline to 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)
Time Frame: Baseline to 8 weeks
The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.
Baseline to 8 weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)
Time Frame: Baseline to 8 weeks
The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Torbjörn Lundström, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M10-667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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