- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00865228
Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
A Double-blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in the Morning vs Lapaquistat Acetate 100 mg in the Evening vs Lapaquistat Acetate 50 mg Twice Daily vs Placebo in Subjects With Hypercholesterolemia
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Dyslipidemias are a group of metabolic disorders produced by raised concentrations of lipoproteins, especially low-density lipoprotein cholesterol the lipoprotein that transports endogenous cholesterol from the liver to the peripheral tissues. Increased cholesterol and triglyceride levels lead to an increased risk of arteriosclerosis, 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.
Lapaquistat acetate is being developed by Takeda for the treatment of hypercholesterolemia.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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California
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Long Beach, California, Yhdysvallat
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Sacramento, California, Yhdysvallat
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San Diego, California, Yhdysvallat
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Florida
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Hollywood, Florida, Yhdysvallat
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Jacksonville, Florida, Yhdysvallat
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New Port Richey, Florida, Yhdysvallat
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Illinois
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Chicago, Illinois, Yhdysvallat
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Kansas
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Wichita, Kansas, Yhdysvallat
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Kentucky
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Louisville, Kentucky, Yhdysvallat
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New Jersey
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Margate, New Jersey, Yhdysvallat
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North Carolina
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Charlotte, North Carolina, Yhdysvallat
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Raleigh, North Carolina, Yhdysvallat
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Statesville, North Carolina, Yhdysvallat
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Wilmington, North Carolina, Yhdysvallat
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Winston-Salem, North Carolina, Yhdysvallat
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Oregon
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Medford, Oregon, Yhdysvallat
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Pennsylvania
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Perkasie, Pennsylvania, Yhdysvallat
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Sellerville, Pennsylvania, Yhdysvallat
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Tennessee
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Bristol, Tennessee, Yhdysvallat
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Virginia
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Norfolk, Virginia, Yhdysvallat
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Richmond, Virginia, Yhdysvallat
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Wisconsin
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Madison, Wisconsin, Yhdysvallat
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Has prior to Randomization a mean low-density lipoprotein cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL for 2 consecutive samples.
- Has prior to Randomization mean triglycerides less than 400 mg/dL for 2 consecutive samples.
- Is willing and able to comply with a standardized, therapeutic lifestyle change diet or equivalent.
Exclusion Criteria:
- Has an alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of normal during the screening period.
- Has a serum creatinine greater than133 mmol/L during the screening period.
- Has a creatine phosphokinase greater than 3 times the upper limit of normal, identified during the screening period.
- Has active liver disease or jaundice.
- Has a history of cancer that has been in remission for less than 5 years prior to the first dose of study medication.
- Has an endocrine disorder, such as Cushing 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, abdomin al aorticaneurysm, coronary angioplasty, coronary or peripheral arterial surgery or multiple risk factors that confer a 10-year risk for cardiovascular disease greater than 20% based on Framingham risk scoring.
- Has a positive hepatitis B surface antigen, or antibody to hepatitis C virus, as determined by medical history and/or subject's verbal report.
- 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 compound within 30 days prior to screening Visit 1, or is currently participating in another 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.
- Has fibromyalgia, myopathy, rhabdomyolysis, or unexplained muscle pain.
- Has uncontrolled hypertension despite treatment at Screening Visit 1.
- Has had inflammatory bowel 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 alcohol abuse within the past 2 years.
- Has stage I squamous cell carcinoma of the skin.
- Has type 1 or type 2 diabetes mellitus.
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
- Fluvastatin
- Lovastatin
- bile acid sequestrants (eg, cholestyramine)
- intestinal cholesterol uptake inhibitors (eg, ezetimibe)
- Fibrates (eg, fenofibrate, gemfibrozil)
- Niacin
- Cholestin
- red yeast rice
- fish oils
- plant sterols and stanols
- orlistat
- sibutramine
- isotretinoin
- tacrolimus
- Probucol
- Systemic corticosteroids and androgens
- Potent CYP3A4 inhibitors
- Cyclosporine
- Erythromycin
- Clarithromycin
- Telithromycin
- human immunodeficiency virus protease inhibitors
- amiodarone
- diltiazem
- verapamil
- nefazodone
- grapefruit juice
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Placebo BID
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Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
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Kokeellinen: Lapaquistat Acetate 100 mg QD (morning)
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Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
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Kokeellinen: Lapaquistat Acetate 100 mg QD (evening)
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Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
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Kokeellinen: Lapaquistat Acetate 50 mg BID
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Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
Aikaikkuna: Week 6
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Week 6
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Prosenttimuutos lähtötilanteesta korkeatiheyksisessä lipoproteiinikolesterolissa
Aikaikkuna: Viikko 6
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Viikko 6
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Change from Baseline in Total Cholesterol
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein B
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein A1
Aikaikkuna: Week 6
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Week 6
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Change from Baseline in Triglycerides
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in derived ratio of Low-Density Lipoprotein Cholesterol / High-Density Lipoprotein Cholesterol
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in derived ratio of Total Cholesterol / High-Density Lipoprotein Cholesterol
Aikaikkuna: Week 6
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Week 6
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Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
Aikaikkuna: Week 6
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Week 6
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Change from Baseline in high sensitivity C-Reactive Protein.
Aikaikkuna: Week 6
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Week 6
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: VP, Clinical Science, Takeda
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- TAK-475_201
- U1111-1122-8404 (Rekisterin tunniste: WHO)
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Kliiniset tutkimukset Lapaquistat acetate
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Karolinska InstitutetValmisLämpötilan muutos, runko | HypovolemiaRuotsi