Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
2012년 5월 23일 업데이트: Takeda
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
The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.
연구 개요
상태
종료됨
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
224
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Long Beach, California, 미국
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Sacramento, California, 미국
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San Diego, California, 미국
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Florida
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Hollywood, Florida, 미국
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Jacksonville, Florida, 미국
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New Port Richey, Florida, 미국
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Illinois
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Chicago, Illinois, 미국
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Kansas
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Wichita, Kansas, 미국
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Kentucky
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Louisville, Kentucky, 미국
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New Jersey
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Margate, New Jersey, 미국
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North Carolina
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Charlotte, North Carolina, 미국
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Raleigh, North Carolina, 미국
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Statesville, North Carolina, 미국
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Wilmington, North Carolina, 미국
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Winston-Salem, North Carolina, 미국
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Oregon
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Medford, Oregon, 미국
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Pennsylvania
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Perkasie, Pennsylvania, 미국
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Sellerville, Pennsylvania, 미국
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Tennessee
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Bristol, Tennessee, 미국
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Virginia
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Norfolk, Virginia, 미국
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Richmond, Virginia, 미국
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Wisconsin
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Madison, Wisconsin, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약 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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실험적: 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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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실험적: 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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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실험적: 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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Percent change from Baseline in the Fasting Plasma Low-Density Lipoprotein Cholesterol concentration
기간: Week 6
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Week 6
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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고밀도 지단백 콜레스테롤의 기준선 대비 백분율 변화
기간: 6주차
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6주차
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Change from Baseline in Total Cholesterol
기간: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein B
기간: Week 6
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Week 6
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Percent change from Baseline in apolipoprotein A1
기간: Week 6
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Week 6
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Change from Baseline in Triglycerides
기간: Week 6
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Week 6
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Percent change from Baseline in Very Low-Density Lipoprotein Cholesterol
기간: Week 6
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Week 6
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Percent change from Baseline in non- High-Density Lipoprotein Cholesterol
기간: 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
기간: 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
기간: Week 6
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Week 6
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Percent change from Baseline in derived ratio of apolipoprotein B / apolipoprotein A1
기간: Week 6
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Week 6
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Change from Baseline in high sensitivity C-Reactive Protein.
기간: Week 6
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Week 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: VP, Clinical Science, Takeda
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 7월 1일
기본 완료 (실제)
2007년 11월 1일
연구 완료 (실제)
2007년 11월 1일
연구 등록 날짜
최초 제출
2009년 3월 18일
QC 기준을 충족하는 최초 제출
2009년 3월 18일
처음 게시됨 (추정)
2009년 3월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 5월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 5월 23일
마지막으로 확인됨
2012년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Lapaquistat acetate에 대한 임상 시험
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Takeda종료됨고콜레스테롤혈증프랑스, 영국, 미국, 이스라엘, 폴란드, 캐나다
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Fujian Shengdi Pharmaceutical Co., Ltd.모병
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Ambrilia Biopharma, Inc.완전한