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

Phase 2

Completed

• Conditions: Intermittent Claudication; Peripheral 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-01-19
• Study First Submitted QC: 2005-01-19
• Study First Posted: 2005-01-20
• Study Completion: 2006-04
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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.

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

Trial Locations

Locations (1)

Investigator; 🇺🇸 Tacoma, Washington, United States