Status:
COMPLETED
Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication
Lead Sponsor:
Diffusion Pharmaceuticals Inc
Conditions:
Intermittent Claudication
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in alleviating the sympt...
Detailed Description
Peripheral Artery Disease (PAD) is a manifestation of systemic atherosclerosis, and patients with PAD commonly manifest symptoms of intermittent claudication (IC) such as cramping, aching, or fatigue ...
Eligibility Criteria
Inclusion
- Aged 40 or older, male or female
- 6-mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD)
- Diagnosis of PAD secondary to atherosclerosis
- If ankle-brachial index (ABI) is \> 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) ≤ 0.7 in at least 1 leg
- Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study
- On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline
- Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study
- Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN
- Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures
- Willing and able to comply with all study-related procedures
- Sexually active patients must use an acceptable method of contraception while participating in the study
- Females of childbearing potential must have a negative pregnancy test at SCRN and have additional pregnancy tests during the study
Exclusion
- Pregnant or lactating
- Current or history of critical limb ischemia (CLI)
- Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder
- Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions
- A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN
- Walking limited by reasons other than claudication
- Conditions other than IC of significant severity that could confound PWT on the ETT
- Concurrent severe congestive heart failure (CHF)
- Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL)
- Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL
- Renal and/or carotid revascularization procedure within 3 mo. of ENRL
- Transient ischemic attack (TIA) within 3 mo. before ENRL
- Deep vein thrombosis (DVT) within 3 mo. before ENRL
- Severe chronic obstructive pulmonary disease (COPD)
- Thrombocytopenia
- Undergoing hemodialysis or peritoneal dialysis
- Pts. w/immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy
- Neurological dementia
- Stroke
- Clinically significant electrocardiogram (ECG) change during or after ETT at SCRN or Baseline visit(s)
- Cerebrovascular infarct within 3 mo. of SCRN
- Poorly controlled type 1 or type 2 diabetes at SCRN
- History of migraine headaches within last 12 mo.
- Patients with clinically significant abnormal hematology labs or blood chemistry labs
- Body mass index \> 35
- Hypertension at SCRN defined as resting BP values of \> 170 mmHg systolic and/or \> 110 mmHg diastolic
- Hypotension at SCRN defined as resting BP values \< 100 mmHg systolic or \< 55 mmHg diastolic or symptomatic hypotension
- Previous treatment with any formulation of TSC
- Known allergy or hypersensitivity to any excipient (gamma-cyclodextrin, mannitol, glycine) of TSC formulation
- Previous treatment with gene therapy or other VEGF-related treatment within 12 mo. of SCRN
- Patients with recent history of alcoholism or drug abuse, or severe emotional, behavioral, or psychiatric problems
- Patients receiving experimental medications or participating in other study using an experimental drug or procedure within 45 days prior to ENRL
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00725881
Start Date
August 1 2008
End Date
March 1 2010
Last Update
July 29 2011
Active Locations (7)
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1
Cardiology, P.C.
Birmingham, Alabama, United States, 35211
2
Radiant Research, Inc.
Santa Rosa, California, United States, 95405
3
Stanford University School of Medicine, Division of Cardiovascular Medicine
Stanford, California, United States, 94305-5406
4
Andrews Research and Education
Pensacola, Florida, United States, 32561