Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nissan Chemical Industries
• Treatments: Phosphodiesterase Inhibitors

Criteria

Inclusion Criteria:

• Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities

• Median treadmill peak walking time between 90 and 600 seconds

Exclusion Criteria:

• 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.