EUCTR2006-004275-35-FR进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II. - ACCELA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •Inclusion criteria at screening period
- •Diagnosis of intermittent claudication (PAD Fontaine stage II):
- •1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
- •2. ICD (Initial claudication distance) of 30 to 250 m at screening constant workload treadmill test.
- •Confirmation of underlying PAD:
- •3. Ankle/Brachial Index (ABI) of 0.90 to 0.5 or for patients with an ABI greater than 1.3 (due to non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.
- •Inclusion criteria at randomization
- •Confirmation of symptom stability:
- •4. Mean ICD of 30 to 250 m calculated by averaging the constant workload treadmill test performed at the end of the run-in phase and the previous one performed at screening.
- •5. The maximum change (measured in log) in the claudication distance should not exceed 0.25 between those two ICD measurements, as per international recommendation.
- •6. The patient is not allowed to smoke 3 hours before treadmill / ABI tests.
- •Appropriate background therapy:
- •7. The patients must have optimal cardiovascular risk prevention and appropriate management of PAD, including clopidogrel 75mg per day, during the study treatment period.
- •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
- •Exclusion criteria at screening / randomization visits
- •1. Patient not having provided written informed consent.
- •2. Patient participated in investigational clinical trials in the last 2 months prior screening.
- •3. Pregnant or breast-feeding woman or woman without documented birth control measures for at least 3 months prior to randomization.
- •Potentially non-atherosclerotic and/or severe stage disease not amenable to medical therapy:
- •4. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years.
- •5. Non-atherosclerotic peripheral arteriopathy (e.g. Buerger’s disease, aneurismal states, popliteal entrapment syndrome).
- •6. Acute peripheral ischemia e.g. thrombosis in situ, trauma, paradoxical embolism of venous thrombi.
- •7. Critical limb ischemia (equivalent to Fontaine stages III and IV), manifested by ischemic rest pain or trophic lesions.
- •Recent (within 3 months prior to screening) pharmacological treatment likely to interfere with study endpoints:
- •8. Recent initiations or discontinuation of treatment by vasoactive agents (e.g. pentoxifylline, beraprost sodium, papaverine, isoxsuprine, nylidrin, cyclandelate and niacin derivatives). Patients treated by cilostazol within 3 months prior to screening will also be excluded.
- •9. Concomitant treatment with sildenafil or other drug of the same class, from start of the run-in phase, until the end of the trial.
- •Recent (within 3 months prior to screening or during the run-in phase) changes in local and/or general conditions likely to interfere with study endpoints:
- •10. Recent lower-extremity surgical or endovascular arterial reconstructions or sympathectomy, or recent deep venous thrombosis.
- •11. Recent change in the level of compliance to supervised or unsupervised program of exercise training and smoking status.
- •12. Recent occurrence of at least one of the following: acute myocardial infarction (MI), unstable angina (UA), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), transient ischemic attack (TIA) or stroke; symptomatic cardiac arrhythmias or significant conduction disturbances.
- •Presence of medical and/or social conditions that would either interfere with participation in the trial, or lead to inability to complete the trial:
- •13. Conditions other than claudication, limiting their exercise capacity, likely to jeopardize completion and/or safety of the treadmill testing, according to investigator’s judgment.
- •14. Planned cardiac or vascular surgery or angioplasty or any major surgery within the next 6 months.
- •15. Severe concomitant disease such that the patient is not expected to survive 6 months.
- •16. Receipt of any investigational treatment (drug or device) within the previous 2 months.
- •17. Inadequate control of hypercholesterolemia and diabetes mellitus.
- •18. Geographic or social factors making study participation impractical.
- •Contra-indications to the use of clopidogrel, cilostazol, or conditions likely to affect
- •pharmacokinetics of cilostazol and/or comedication:
- •19. Contra-indication to the use of clopidogrel.
- •20. CHF of any severity.
- •21. History of drug allergy to cilostazol or HMR1766.
- •22. Severe hepatic disease (hepatic enzymes>3times ULN).
- •23. Severe renal failure (serum creatinine greater than 2.5 mg/dL).
- •24. Requirement for systemic administration of inhibitors of CYP3A4 such as ketoconazole, itraconazole, erythromycin, diltiazem, as well as substrates of CYP2C9 such as warfarin, fluvastatin.
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