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HypercholesterolemiaPhase 3NCT00532558

Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With Hypercholesterolemia

A Phase 3 study testing Lapaquistat acetate in people with Hypercholesterolemia, run by Takeda at 60 sites in 11 countries.

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 reduction of LDL-cholesterol level after treatment with 50 mg per day 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
Hypercholesterolemia
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
657 participants
Where
60 sitesin 11 countries
Study dates
Oct 2007to May 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.
  • Prior to Randomization, the participant has a mean low density lipoprotein cholesterol level greater than or equal to 130 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 fibrates within 42 days of Visit 1 or any lipid-lowering therapy for at least 30 days prior to Screening.
  • 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

60 sites in 11 countries.

60 sites in 11 countries

Israel8 sites

  • Study site

    Beersheba

  • Study site

    Hadera

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Nahariya

  • Study site

    Safed

  • Study site

    Tel Aviv

Other trials in Israel

Netherlands8 sites

  • Study site

    Amsterdam

  • Study site

    Breda

  • Study site

    GA Nijmegen

  • Study site

    Groningen

  • Study site

    Hoorn

  • Study site

    Rotterdam

  • Study site

    Utrecht

  • Study site

    Zoetermeer

Other trials in Netherlands

Hungary6 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Érd

  • Study site

    Pécs

  • Study site

    Szekszárd

Other trials in Hungary

Slovakia6 sites

  • Study site

    Bratislava

  • Study site

    Dolný Kubín

  • Study site

    Košice

  • Study site

    Nitra

  • Study site

    Nové Mesto nad Váhom

  • Study site

    Trebišov

Other trials in Slovakia

Ukraine6 sites

  • Study site

    Dnipro

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lutsk

  • Study site

    Lviv

Other trials in Ukraine

United Kingdom6 sites

  • Study site

    Belfast

  • Study site

    Bolton

  • Study site

    Glasgow, Scotland

  • Study site

    Oldham

  • Study site

    Paignton, Devon

  • Study site

    Sheffield

Other trials in United Kingdom

Norway5 sites

  • Study site

    Ålesund

  • Study site

    Elverum

  • Study site

    Hamar

  • Study site

    Kongsberg

  • Study site

    Oslo

Other trials in Norway

Russia5 sites

  • Study site

    Moscow

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Tyumen

  • Study site

    Volgograd

Other trials in Russia

Spain5 sites

  • Study site

    Córdoba

  • Study site

    Madrid

  • Study site

    Pontevedra

  • Study site

    REUS (Tarragona)

  • Study site

    Valencia

Other trials in Spain

Latvia3 sites

  • Study site

    Daugavpils

  • Study site

    Kuldīga

  • Study site

    Riga

Other trials in Latvia

Estonia2 sites

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

About this study

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

The purpose of the study is to determine the reduction of LDL-cholesterol level after treatment with 50 mg per day of lapaquistat acetate once daily (QD).

Read the detailed description

This study is being conducted to determine the potential of lapaquistat acetate 50 mg per day to lower LDL-C levels compared with placebo. This study is also being conducted to further evaluate the safety and tolerability of lapaquistat acetate 50 mg over a period of 12 weeks. An optional, 48-week, open-label extension will follow the 12 week, double-blind treatment period to evaluate the long-term safety and tolerability of lapaquistat acetate 50 mg/day.

Being tested
Lapaquistat acetate, Placebo
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 acetateDrug

    Also called TAK-475

    Lapaquistat acetate 50 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 NCT00532558
Study groupRoleWhat they receive
Lapaquistat Acetate 50 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 fasting plasma Low Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

Secondary outcomes (10)

  1. Change from Baseline in Total 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 Very Low Density Lipoprotein cholesterol

    Measured: Week 12 or Final Visit

  4. Change from Baseline in apolipoprotein A1 Timeframe: Week 12 or Final Visit

    Measured: Week 12 or Final Visit

  5. Change from Baseline in apolipoprotein B

    Measured: Week 12 or Final Visit

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

    Measured: Week 12 or Final Visit

  7. Change from Baseline in the ratio of Low Density Lipoprotein cholesterol/High Density Lipoprotein 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 the ratio of apolipoprotein A1/apolipoprotein B

    Measured: Week 12 or Final Visit

  10. Change from Baseline in Triglycerides

    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 startOct 2007
  3. Primary completionMay 2008
  4. Study completionMay 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
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532558
Sponsor's protocol ID
TAK-475_306
Other IDs
U1111-1122-8417
Status last verified
May 2012
First submitted
18 Sep 2007
Last updated
24 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapaquistat acetate in people with Hypercholesterolemia, run by Takeda at 60 sites in 11 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 4 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 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 60 sites in Israel, Netherlands, Hungary, Slovakia, Ukraine and 6 more countries. 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 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 NCT00532558.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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