Phase 3 multi-center, double-blind, randomized, parallel group evaluation of the fixed combination torcetrapib/atorvastatin, administered orally, once daily (QD), compared with atorvastatin alone, on the occurrence of major cardiovascular events in subjects with coronary heart disease or risk equivalents - N/A

Pfizer SA0 个研究点目标入组 13,000 人开始时间: 2004年9月16日最近更新: 2022年4月19日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Pfizer SA
入组人数: 13,000

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
•1.Subjects with high risk of CVD events defined as any of the following:
•a. Prior myocardial infarction in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit.
•b. Previous cardiac revascularization procedure prior to screening (see protocol for more details)
•c. Pre existing atherosclerotic CHD (documented acute coronary syndrome including unstable angina) in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit. (see protocol for more details)
•d. Pre existing symptomatic carotid artery disease (documented prior stroke defined as persistent brain deficit lasting more than 24 hours with a demonstrable lesion by CT or MRI scan) at least one month (30 days) prior to screening.
•e. Pre existing PVD; documented as either a peripheral intervention [at least one month (30 days) prior to screening] or ankle/brachial index (ABI) <0.9.
•f. Prior diagnosis of type 2 diabetes including subjects currently on hypoglycemic agents or insulin, and/or according to American Diabetes Association (ADA) criteria.
•2. Subjects eligible for statin (HMG CoA reductase inhibitor) treatment defined as:
•a. On a statin or other prescription lipid altering treatment at screening, or
•b. LDL C ³100 mg/dL (2.6 mmol/L) if not on a prescription lipid altering treatment at screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•Subjects presenting with any of the following will not be included in the trial:
•1. Women who are pregnant, lactating, or who are planning to become pregnant Women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (eg, hormonal contraception, intrauterine device, barrier method plus spermicide).
•2. Subjects at Visit 1 who are not on prior prescription lipid-altering treatment, and have an LDL C of <100 mg/dL (2.6 mmol/L).
•3. Subjects who at the final atorvastatin only run in visit (ie, subjects are on 80 mg atorvastatin daily), fail to reach the target LDL C of <100 mg/dL (2.6 mmol/L)
•4. Subjects who have participated in long term (³3 years) cardiovascular endpoint trials anytime within the 12 months prior to screening/Visit 1.
•5. Subjects or are planned after randomization a coronary angioplasty, CABG, other cardiovascular surgery (eg, valve replacement), or other peripheral intervention; or experiencing a CVD event (eg, MI, stroke) within 30 days (exclusive) of the screening visit or during the atorvastatin only run in period.
•6. Subjects with severe pre existing CHD that limits their expected ability to complete the trial or their life expectancy (please see protocol for further details).
•7. Subjects with uncontrolled hypertension, defined as an average SBP >140 mmHg or an average diastolic blood pressure (DBP) >90 mmHg, at baseline. Subjects with an average SBP >140 mmHg or DBP >90 mmHg at screening or any run in visit (Visits 2 6) should receive appropriate treatment for hypertension.
•8. Fasting triglycerides >500 mg/dL (5.6 mmol/L) at Visit 1 or 2.
•9. Subjects receiving the following concomitant lipid-altering therapy ( non statins and statins) or therapies affecting LDL-C, HDL-C and TG at Visit 1:
•10. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG CoA reductase inhibitors.
•11.Subjects with any other medical condition or laboratory abnormality prior to randomization, which in the opinion of the principal investigator could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study, including but not limited to:
•a. Subjects with uncontrolled diabetes mellitus;
•b. Subjects with renal disease
•c. Subjects with uncontrolled hypothyroidism defined as a TSH >2 times the ULRR at Visit 1;
•d. Subjects with any active hepatobiliary disease (including cirrhosis), serologic evidence of past or active hepatitis B or hepatitis C infection, or an AST or ALT >2 times the ULRR, alkaline phosphatase >1.5 times the ULRR with elevated liver isoform of alkaline phosphatase or total bilirubin >1.5 times the ULRR at Visit 1 or 2;
•e. Subjects with unexplained serum CK >3 times the ULRR at Visit 1 or 2 (eg, not due to recent trauma, intramuscular injections, heavy exercise). A repeat CK >3 times ULRR in the absence of conditions explaining CK elevation is exclusionary;
•f. Subjects with any prior history of malignancy.
•g. Subjects with gastrointestinal disease limiting drug absorption or partial ileal bypass, gastric stapling, or gastric binding;
•h. Subjects with alcohol and/or any other drug abuse or dependence.

研究者

发起方

Pfizer SA

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