NCT00251849Unknown3 期
Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients
ActivBiotics93 个研究点 分布在 3 个国家目标入组 274 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 274
- 试验地点
- 93
- 主要终点
- The efficacy endpoint is change from baseline in PWT
研究概览
简要总结
The objective of this study is to determine whether rifalazil can significantly increase peak walking time (PWT) in patients with peripheral arterial disease (PAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 40 and 80 years of age, inclusive.
- •The patient has seropositive evidence of Chlamydia pneumoniae defined by immunoglobulin G antibody titers.
- •The patient has a diagnosis of intermittent claudication due to PAD at screening.
- •The patient's maximal effort PWT is limited only by severe claudication symptoms.
- •If the patient is taking cilostazol or pentoxifylline and has been on a stable dose of the medication for at least 6 months prior to screening. Patients who have recently discontinued medications for PAD and/or intermittent claudication must "wash-out" for at least one month prior to screening.
- •The patient has been on a stable dose of statin therapy for at least 6 months prior to screening.Patients who have recently discontinued statin therapy must "wash-out" for at least one month prior to screening.
- •Male and female patients must agree to use an effective form of birth control throughout the study period.
排除标准
- •The patient has critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene.
- •The patient has had a major amputation of the leg or any other amputation that limits walking ability.
- •The patient is planned for surgical/endovascular intervention for PAD during the course of the study.
- •The patient has or is being treated or evaluated for tuberculosis.
- •The patient has a known immunodeficient state (e.g., positive for human immunodeficiency virus) or is being treated with immunosuppressive drugs including high dose steroids or cyclosporine.
- •The patient has an active infection requiring systemic or oral antibiotics.
- •The patient has an uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis. Patients who develop autoimmune disease during the course of the study must be withdrawn.
- •The patient's PWT is limited by symptoms other than claudication (shortness of breath, fatigue, angina, or arthritis).
- •The patient has a history of alcohol abuse, illicit drug use or drug abuse or significant mental illness.
- •The patient has a known or suspected allergy to the study medication(s) or class of study medication (rifamycins) to be administered.
- •The patient chronically uses antibacterials or has previously received rifalazil or any rifamycin (e.g. rifampin).
- •The patient has uncontrolled hypertension (resting blood pressure > 160/100 mm Hg), uncontrolled moderate to severe congestive heart failure (CHF), or uncontrolled arrhythmic disorders.
结局指标
主要结局
The efficacy endpoint is change from baseline in PWT
The safety endpoints are adverse event rates, rates of clinically significant laboratory abnormalities, vital signs, and physical exam abnormalities, rate of vascular death, myocardial infarction (MI), stroke, revascularization or vascular procedures
次要结局
未报告次要终点
研究者
研究点 (93)
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