NL-OMON49686撤回2 期
A 12-week, multi-center, double-blinded, parallelgroup, randomized, placebo-controlled phase IIb study to evaluate the safety, tolerability and efficacy of IZD334 to reduce CRP in cardiovascular high-risk patients. - IZD334-002
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed and dated informed consent form obtained before any study assessment
- •is performed
- •2. Male or female patients aged *18 years
- •3. Stable coronary artery disease (CAD) where stable coronary artery disease
- •refers to any of the following:
- •a. a reversible supply/demand mismatch related to ischemia or
- •b. a history of myocardial infarction (minimum 30 days prior to randomization)
- •c. the presence of coronary artery plaque of any severity documented by cardiac
- •catheterization or computed tomography angiography.
- •Patients are considered stable if they are asymptomatic or their symptoms are
- •adequately controlled by medications or revascularization.
- •4. Elevated plasma CRP level of * 2 mg/L at screening visit 1 (local lab) and
- •confirmed at screening visit 2 by central lab
- •5. Negative pregnancy test for females of child-bearing potential
- •(premenopausal, * 2 years post-menopausal, not surgically sterile)
- •6. Stable concomitant medication for at least 4 weeks prior to randomization
- •7. Patients with creatinine clearance * 30 mL/min/1.73m2 by the MDRD
- •(modification of diet in renal disease) equation may be included
排除标准
- •1. Any use of NSAIDs or steroids or cholchicine or anti-IL-1 inhibitors within
- •4 weeks prior to randomization (ASS 100mg as part of SOC treatment is allowed /
- •topical, inhaled, local steroid use in doses that are not considered to cause
- •systemic effects are permitted)
- •2. Any investigational drugs or participation in a clinical trial within 4
- •weeks or five half-lives (whichever is longer) prior to randomization
- •3. Active systemic infections (other than common cold) during the two weeks
- •prior to randomization
- •4. Positive test for hepatitis B virus surface antigen (HBsAg) or Hepatitis C
- •virus RNA at screening
- •5. Positive test for HIV at screening
- •6. History of severe hypersensitivity according to the investigator*s judgement
- •to previous drugs of similar chemical classes
- •7. Any severe, progressive or uncontrolled medical condition at baseline that
- •in the judgment of the investigator prevents the patient from participating in
- •the study including uncontrolled hypertension, uncontrolled diabetes and severe
- •hepatic disease
- •8. Symptomatic patients with Class IV heart failure (HF) (New York Heart
- •Association)
- •9. Planned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass
- •Grafting (CABG)
- •10. Any clinically significant abnormal laboratory tests at screening
- •11. A history of alcohol and/or substance abuse that could interfere with the
- •conduct of the trial
- •12. Inability or unwillingness to undergo repeated venipunctures (e.g., due to
- •poor tolerability or lack of access to veins)
- •13. Pregnant or nursing (lactating) women, where pregnancy is defined as the
- •state of a female after conception and until the termination of gestation,
- •confirmed by a positive human chorionic gonadotropin (HCG) laboratory test (> 5
- •14. Women of childbearing potential unwilling or unable to practice effective
- •method of contraception
研究者
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