A multi-center, double-blind, randomized, placebo-controlled study to assess the pharmacodynamics, pharmacokinetics, tolerability, and safety of a single subcutaneous injection of ACT-246475 in adults with stable coronary artery disease

Idorsia Pharmaceuticals Ltd.0 个研究点目标入组 324 人开始时间: 2017年11月17日最近更新: 2018年10月15日

适应症

试验速览

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•1. Signed informed consent prior to any study-mandated procedure.
•2. Male and female subjects aged from 18–85 years, inclusive.
•3. For women of childbearing potential: Negative urine pregnancy test at Visit 1 and at Visit 2 before randomization.
•4. Stable CAD defined by the presence of any of the following conditions:
•a. History of CAD with coronary artery stenosis on coronary angiogram = 50%.
•b. Previously documented myocardial infarction occurring more than 3 months prior to randomization.
•5. Antiplatelet background therapy stable for at least 1 month prior to randomization.
•6. Body weight = 40.0 kg (88.2 lbs).
•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 124
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1. Acute coronary syndrome, percutaneous coronary intervention or any intervention for peripheral artery disease within 3 months prior to randomization.
•2. Acute ischemic stroke or transient ischemic attack (TIA) within 3 months prior to randomization.
•3. Active internal bleeding, or medical history of recent (< 1 month) bleeding disorders or conditions associated with high risk of bleeding (e.g., clotting disturbances, gastrointestinal bleed, hemoptysis).
•4. Hemoglobin = 10 g/dL at screening.
•5. Loss of at least 250 mL of blood within 3 months of screening.
•6. Use of anticoagulants (oral, parenteral) or fibrinolytic therapy within 24 h prior to screening (Visit 1).
•7. Known platelet disorders (e.g., thrombasthenia, thrombocytopenia, von Willebrand disease).
•8. Pregnant or breastfeeding women.

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