Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
- Conditions
- Intermittent ClaudicationPeripheral Vascular Disease
- Registration Number
- NCT00102050
- Lead Sponsor
- Nissan Chemical Industries
- Brief Summary
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 taken twice a day (BID) for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.
- Detailed Description
NM-702 oral tablets are being developed for the treatment of Intermittent Claudication, a primary early stage indication of peripheral arterial disease (PAD). This trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg NM-702 BID for 24 weeks to see if it improves peak walking time (PWT) more than placebo for the treatment of Intermittent Claudication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
- Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
- Median treadmill peak walking time between 90 and 600 seconds
- Symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene)
- Clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing
- Subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation.
- A resting blood pressure greater than 150/100 and other clinically significant results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement in peak walking time at 24 weeks
- Secondary Outcome Measures
Name Time Method Improvement in claudication onset time at 24 weeks Health status survey questionnaire Walking impairment questionnaire
Related Research Topics
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Trial Locations
- Locations (1)
Investigator
🇺🇸Tacoma, Washington, United States
Investigator🇺🇸Tacoma, Washington, United States