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

Nissan Chemical Industries

Status and phase

Completed

Phase 2

Conditions

Peripheral Vascular Disease

Intermittent Claudication

Treatments

Drug: NM-702 (phosphodiesterase inhibitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102050

NCI-IC-0201

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.