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DyslipidemiaPhase 3NCT00143663

Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol

A Phase 3 study testing Lapaquistat Acetate in people with Dyslipidemia, run by Takeda at 47 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

The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidemia
What is being tested?
Lapaquistat Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
361 participants
Where
47 sitesUnited States
Study dates
Sep 2005to Apr 2006
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

  • Female participants of childbearing potential cannot be been pregnant, lactating and are not planning on becoming pregnant and agrees to use acceptable forms of contraception throughout the course of this study.
  • Must have a mean low-density lipoprotein cholesterol values between 3.367 and 5.689 mmol/L, inclusive, from 2 consecutive samples taken at least 1 week apart with the difference between the 2 values not exceeding 15% of the higher value.
  • Must have a triglyceride value of 4.516 mmol/L or less from 2 consecutive samples taken at least 1 week apart with the upper value from either sample being 5.081 mmol/L or less.
  • Has clinical laboratory evaluations within the reference ranges for the testing laboratory unless the results were deemed not clinically significant by the investigator or sponsor.
  • Is willing and able to maintain a standardized low-cholesterol diet.

Who cannot join

  • Has an alanine aminotransferase or aspartate aminotransferase level greater than 1.5 times the upper limit of normal, active liver disease or jaundice.
  • Has a serum creatinine level greater than 135 μmol/L.
  • Has a creatine phosphokinase value greater than three times the upper limit of normal.
  • Has diabetes mellitus type 1 or 2.
  • Has a history of cancer that had been in remission for less than 5 years prior to the first dose of study drug. This criterion did not include subjects with basal cell or stage I squamous cell carcinoma of the skin.
  • Has an endocrine disorder, such as Cushing syndrome, hyperthyroidism, or inappropriately treated hypothyroidism, affecting lipid metabolism.
Show all 18Show fewer
  • Has a history of myocardial infarction, angina pectoris, transient ischemic attacks, cerebrovascular accident, peripheral vascular disease, abdominal aortic aneurysm, coronary revascularization or multiple risk factors that present a 10-year risk for CHD of greater than 20%, based on Framingham risk scoring.
  • Has a positive hepatitis B surface antigen or hepatitis C virus antibody, as determined by medical history and/or participant's verbal report.
  • Has a positive human immunodeficiency virus test result or was taking antiretroviral medications, as determined by medical history and/or subject's verbal report.
  • Is unable or unwilling to discontinue excluded medications or to continue stable doses of "stable dose" medications or would require treatment with any excluded medication during the study.
  • Has had exposure to lapaquistat acetate in other studies or was participating or enrolled in another investigational study within the previous 30 days or, for drugs with a long half-life, within a period of less than 5 times the drug's half-life.
  • Has a history or presence of a clinically significant food allergy that would prevent adherence to the therapeutic lifestyle change (or equivalent) 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 inflammatory bowel disease or any other malabsorption syndrome or had gastric bypass or any other surgical procedure for weight loss.
  • Has a history of drug abuse or alcohol abuse within the past 2 years.
  • Has any other serious disease or condition at Run-In or at Randomization that might reduce life expectancy, impair successful management according to the protocol, or make the subject an unsuitable candidate to receive study drug.

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Study site

    Arkansas City, Kansas

  • Study site

    Aventura, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chula Vista, California

  • Study site

    Clearwater, Florida

  • Study site

    Dallas, Texas

  • Study site

    Daytona Beach, Florida

  • Study site

    Downingtown, Pennsylvania

  • Study site

    Elk Grove Village, Illinois

  • Study site

    Encinitas, California

  • Study site

    Evansville, Indiana

  • Study site

    Golden, Colorado

  • Study site

    Hollywood, Florida

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Livonia, Michigan

  • Study site

    Long Beach, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Margate City, New Jersey

  • Study site

    Medford, Oregon

  • Study site

    Mesa, Arizona

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    New Hyde Park, New York

  • Study site

    New Port Richy, Florida

  • Study site

    Norfolk, Virginia

  • Study site

    Northport, Alabama

  • Study site

    Ogden, Utah

  • Study site

    Pembroke Pines, Florida

  • Study site

    Peoria, Illinois

  • Study site

    Pismo Beach, California

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Sacramento, California

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sellersville, Pennsylvania

  • Study site

    Statesville, North Carolina

  • Study site

    Tipton, Pennsylvania

  • Study site

    Warwick, Rhode Island

  • Study site

    Wichita, Kansas

  • Study site

    Wilmington, North Carolina

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 100 mg Versus Placebo in Subjects With Primary Hypercholesterolemia

The purpose of this study is to determine if patients with elevated cholesterol, but not taking any other lipid medication, could lower their cholesterol with administration of lapaquistat acetate, once daily (QD).

Read the detailed description

This study will evaluate the efficacy and safety of TAK-475 (lapaquistat acetate) compared to placebo in subjects with primary hypercholesterolemia. Subjects who have signed the informed consent will undergo necessary evaluations to determine eligibility for a dietary run-in phase. Subjects who meet randomization criteria will enter treatment with one of the following randomized treatments: lapaquistat acetate or placebo.

Conditions
Dyslipidemia
Being tested
Lapaquistat Acetate, Placebo
Keywords
Hypercholesterolemia, Hyperlipidemia, Drug Therapy
Medical subject headings
Dyslipidemias, Hypercholesterolemia, Hyperlipidemias

What participants receive

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

  • Lapaquistat AcetateDrug

    Also called TAK-475

    Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 12 weeks

  • PlaceboDrug

    Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks

Study groups in NCT00143663
Study groupRoleWhat they receive
Lapaquistat Acetate 100 mg QDExperimentalNot described
Receives: Drug: Lapaquistat Acetate
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change from Baseline in Low-Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

Secondary outcomes (12)

  1. Change from Baseline in Calculated Low-Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  2. Change from Baseline in High-Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  3. Change from Baseline in the ratio of Low-Density Lipoprotein cholesterol/ 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 non- High-Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  6. Change from Baseline in Triglycerides

    Measured: Week 12 or Final Visit

  7. Change from Baseline in Total Cholesterol

    Measured: Week 12 or Final Visit

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

    Measured: Week 12 or Final Visit

  9. Change from Baseline in apolipoprotein A1

    Measured: Week 12 or Final Visit

  10. Change from Baseline in apolipoprotein B

    Measured: Week 12 or Final Visit

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

    Measured: Week 12 or Final Visit

  12. Change from Baseline in High-Sensitivity C-reactive Protein

    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 posted2 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2006
  4. Study completionApr 2006

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
361 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00143663
Sponsor's protocol ID
01-04-TL-475-008
Other IDs
U1111-1122-7722
Status last verified
May 2012
First submitted
31 Aug 2005
Last updated
24 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.

    PubMed 21518985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapaquistat Acetate in people with Dyslipidemia, run by Takeda at 47 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 18 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 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?

Change from Baseline in 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 NCT00143663, which also lists 1 linked publication.

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 24 May 2012.

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