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

Completed · Phase 2

Conditions studied: Intermittent Claudication, Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00102050

Run by

Nissan Chemical Industries

People needed

390

Starts

2003-04-01

Expected to finish

2006-04-01

Last updated by the study team

2006-05-19

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
• Median treadmill peak walking time between 90 and 600 seconds

You may not qualify if…

• 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.

Where it is running

• Investigator — Long Beach, California, United States
• Investigator — Riverside, California, United States
• Investigator — San Diego, California, United States
• Investigator — San Francisco, California, United States
• Investigator — Torrance, California, United States
• Investigator — Clearwater, Florida, United States
• Investigator — Coral Gables, Florida, United States
• Investigator — Jacksonville, Florida, United States
• Investigator — Springfield, Illinois, United States
• Investigator — Shawnee Mission, Kansas, United States
• Investigator — New Orleans, Louisiana, United States
• Investigator — New York, New York, United States
• Investigator — Durham, North Carolina, United States
• Investigator — Toledo, Ohio, United States
• Investigator — Warwick, Rhode Island, United States
• Investigator — San Antonio, Texas, United States
• Investigator — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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