A Phase I/IIa Study investigating the safety and tolerability of intramuscular DVC1-0101 compared with placebo in patients with Intermittent Claudication or Critical Limb Ischaemia Secondary to Peripheral Artery Disease.

CMAX - a division of IDT Australia0 个研究点目标入组 3 人开始时间: 2015年10月28日最近更新: 2022年10月3日

试验速览

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•Diagnosis of PAD secondary to atherosclerosis, confirmed by medical history and one of the following observed in either leg at the screening visit:
•a.Resting ABI less than or equal to 0.90
•b.Resting ABI greater than 0.90 and less than or equal to 1.30, with a reduction of greater than or equal to 0.20 in ABI when measured within 2 minutes after completion of treadmill exercise.
•c.TBI less than 0.75 if the subject has non-compressible calf arteries. i.e. Rutherford category 1-5. (Rutherford RJ, 1997)
•Claudication symptoms of stable severity for at least 3 months prior to screening OR the highest ACD from either the screening or baseline exercise treadmill test (ETT), utilizing a modified Gardner protocol, must be between 1 and 12 minutes (inclusive).

•PAD secondary to non-atherosclerotic conditions.
•Proximal severe obstructive disease amenable to revascularisation.
•Lower extremity amputation(s), including a toe amputation, which interfere(s) with walking on the treadmill.
•Percutaneous revascularization procedure within 3 months prior to Screening, or procedures that are planned during the study.
•Poorly controlled diabetes mellitus as evidenced by a haemoglobin A1C (HbA1c) > 12%.
•Coronary artery bypass graft surgery (CABG), open peripheral vascular revascularization, or major surgical procedures within 3 months prior to screening, or planned at any time during the study
•Unstable cardiovascular disease (CVD), defined as unstable both by clinical criteria and / or major changes in medication within 3 months prior to Screening or Baseline of the Extension Period.
•History of congestive heart failure (CHF) or presence of CHF as defined by modified Framingham criteria class II- IV.
•Myocardial infarction (MI) within 3 months prior to Screening or at Baseline of the Extension Period.

发起方

CMAX - a division of IDT Australia