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HypercholesterolemiaPhase 3NCT00532311

Efficacy of Lapaquistat Acetate Co-Administered With Statins in Subjects With Hypercholesterolemia

A Phase 3 study testing Lapaquistat acetate and stable statin therapy and Stable statin therapy in people with Hypercholesterolemia, run by Takeda at 86 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
Lapaquistat acetate and stable statin therapy and Stable statin therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
411 participants
Where
86 sitesUnited States
Study dates
Jul 2007to Apr 2008
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception from screening throughout the duration of the study and for 30 days following the last dose.
  • Has been on a stable dose of statin for at least 3 months prior to Screening. Participants enrolled in Canada, Latin America, and South Africa must be on the maximum approved dose of statin (atorvastatin 80 mg, simvastatin 80 mg, rosuvastatin 40 mg, pravastatin 80 mg, fluvastatin 80 mg, or lovastatin 80 mg).
  • Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 100 mg/dL and less than or equal to 190 mg/dL for 2 consecutive samples.
  • Prior to Randomization, the subject has mean triglyceride level greater than or equal to 400 mg/dL for 2 consecutive samples.
  • Is willing and able to comply with the recommended, standardized diet.

Who cannot join

  • Has an nine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, identified during screening.
  • Has a serum creatinine greater than 133 mmol/L, identified during screening.
  • Has a creatine kinase greater than 3 times the upper limit of normal, identified during screening.
  • Has active liver disease or jaundice.
  • Has taken any bile acid sequestrants [eg, cholestyramine], and intestinal cholesterol uptake inhibitors [eg, ezetimibe]) from 30 days before Screening until study completion or any fibrates for 6 weeks before Visit 1.
  • Has a previous history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
Show all 19Show fewer
  • Has an endocrine disorder, such as Cushing's syndrome, hyperthyroidism, or inappropriately treated hypothyroidism affecting lipid metabolism.
  • Has a history of myocardial infarction, angina pectoris, unstable angina, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary angioplasty, coronary or peripheral arterial surgery, or multiple risk factors that confer a 10-year risk for cardiovascular heart disease greater than 20% based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen or hepatitis C virus antibody test, as determined by medical history.
  • Has a positive human immunodeficiency virus status or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Has received any investigational medication 30 days prior to screening, (for drugs with a long half-life, within a period of less than 5 times the drug's half-life) or is participating in an investigational study.
  • Has received lapaquistat acetate in a previous clinical study or as a therapeutic agent.
  • Has a history or presence of clinically significant food allergy that would prevent adherence to the specialized diet.
  • Has a known heterozygous or homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia (familial dysbetalipoproteinemia).
  • Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
  • Has uncontrolled hypertension
  • Has had inflammatory bowel disease or any other malabsorption syndrome, or has had gastric bypass or any other surgical procedure for weight loss.
  • Has a history of drug abuse or a history of high alcohol intake within the previous 2 years.
  • Has type 1 or 2 diabetes mellitus.

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

United States86 sites

  • Study site

    Altoona, Pennsylvania

  • Study site

    Ann Arbor, Michigan

  • Study site

    Artesia, California

  • Study site

    Asheville, North Carolina

  • Study site

    Aurora, Illinois

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Bristol, Tennessee

  • Study site

    Brooklyn Center, Minnesota

  • Study site

    Burke, Virginia

  • Study site

    CantonAuburn, Maine

  • Study site

    Chandler, Arizona

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Coral Gables, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Dallas, Texas

  • Study site

    Dowington, Pennsylvania

  • Study site

    Dunwoody, Georgia

  • Study site

    Durham, North Carolina

  • Study site

    Edina, Minnesota

  • Study site

    Evansville, Indiana

  • Study site

    Fort Meyers, Florida

  • Study site

    Gilbert, Arizona

  • Study site

    Glendale, Arizona

  • Study site

    Golden, Colorado

  • Study site

    Goose Creek, South Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Haverhill, Massachusetts

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Irving, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kettering, Ohio

  • Study site

    Long Beach, California

  • Study site

    Louisville, Kentucky

  • Study site

    Margate City, New Jersey

  • Study site

    Mentor, Ohio

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    New Port Richey, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Overland Park, Kansas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Pinellas Park, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Santa Rosa, California

  • Study site

    Sarasota, Florida

  • Study site

    Scarborough, Maine

  • Study site

    Sellerville, Pennsylvania

  • Study site

    Simpsonville, South Carolina

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Statesville, North Carolina

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Tustin, California

  • Study site

    Walnut Creek, California

  • Study site

    Warwick, Rhode Island

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wauwatosa, Wisconsin

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

  • Study site

    Wilwood, New Jersey

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Zanesville, Ohio

Other trials in United States

About this study

Official title: A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 50 mg or Placebo When Co-administered With Statins in Subjects With Hypercholesterolemia, With an Optional Open-Label Extension

The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with statins on cholesterol levels in subjects with hypercholesterolemia

Read the detailed description

Dyslipidemias are a group of metabolic disorders produced by raised concentrations of lipoproteins, especially low-density lipoprotein cholesterol, which is the lipoprotein that transports endogenous cholesterol from the liver to the peripheral tissues. Increased cholesterol and triglycerides levels lead to an increased risk of arteriosclerosis, which is the underlying cause of heart attack, strokes and peripheral vascular disease.

Despite changes in lifestyle and the availability of potent lipid-lowering agents, cardiovascular disease continues to be the major cause of death in Western Europe and North America. Serum cholesterol levels exceeding 5 mmol/L (193 mg/dL) are common in adults in Britain and much of Europe, the United States, Australia and New Zealand.

This study will evaluate the efficacy and safety of lapaquistat acetate taken with either torvastatin, simvastatin, rosuvastatin, pravastatin, fluvastatin or lovastatin (stable statin therapy) in subjects with hypercholesterolemia. Total participation time in this study is expected to be up to 12 weeks, with an optional, 48-week, open-label extension period for participants who qualify.

Being tested
Lapaquistat acetate and stable statin therapy, Stable statin therapy
Keywords
Hyperlipidemia, Drug Therapy
Medical subject headings
Hypercholesterolemia, Hyperlipidemias

What participants receive

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

  • Lapaquistat acetate and stable statin therapyDrug

    Also called TAK-475, Lipitor, Zocor, Crestor

    Lapaquistat acetate 50 mg, tablets, orally, once daily and stable statin therapy for up to 12 weeks.

  • Stable statin therapyDrug

    Also called Lipitor, Zocor, Crestor, Pravachol

    Lapaquistat acetate placebo-matching tablets, orally, once daily and stable statin therapy for up to 12 weeks.

Study groups in NCT00532311
Study groupRoleWhat they receive
Lapaquistat Acetate 50 mg QDExperimental(and stable statin therapy)
Receives: Drug: Lapaquistat acetate and stable statin therapy
Stable statin therapyActive comparatorNot described
Receives: Drug: Stable statin therapy

What is being measured

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

  1. Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

Secondary outcomes (14)

  1. Change from Baseline in Triglycerides

    Measured: Week 12 or Final Visit

  2. Change from Baseline in Total Cholesterol

    Measured: Week 12 or Final Visit

  3. Change from Baseline in High Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  4. Change from Baseline in Very Low Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  5. Change from Baseline in apolipoprotein A1

    Measured: Week 12 or Final Visit

  6. Change from Baseline in apolipoprotein B

    Measured: Week 12 or Final Visit

  7. Change from Baseline in non- High Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  8. Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  9. Change from Baseline in the ratio of Total Cholesterol/High Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  10. Change from Baseline in the ratio of apolipoprotein A1/apolipoprotein B

    Measured: Week 12 or Final Visit

  11. Change from Baseline in high-sensitivity C-reactive protein

    Measured: Week 12 or Final Visit

  12. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 1.81 mmol/L (70 mg/dL)

    Measured: Week 12 or Final Visit

  13. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 2.59 mmol/L (100 mg/dL)

    Measured: Week 12 or Final Visit

  14. Percentage of subjects who achieve Low Density Lipoprotein cholesterol concentrations less than 3.37 mmol/L (130 mg/dL)

    Measured: Week 12 or Final Visit

Timeline

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

  1. First posted20 Sep 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Why it stopped: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
411 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532311
Sponsor's protocol ID
TAK-475_307
Other IDs
U1111-1122-8479
Status last verified
Jun 2016
First submitted
18 Sep 2007
Last updated
22 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapaquistat acetate and stable statin therapy and Stable statin therapy in people with Hypercholesterolemia, run by Takeda at 86 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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 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?

The study was stopped early (reason given: Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents). Results are not available in the source record.

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?

Change from Baseline in fasting plasma Low Density Lipoprotein cholesterol (time frame: Week 12 or Final Visit). 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 NCT00532311.

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 22 Jun 2016.

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