Status:
COMPLETED
Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
Lead Sponsor:
Nissan Chemical Industries
Conditions:
Intermittent Claudication
Peripheral Vascular Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 safe...
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 safe...
Eligibility Criteria
Inclusion
- Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
- Median treadmill peak walking time between 90 and 600 seconds
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00102050
Start Date
April 1 2003
End Date
April 1 2006
Last Update
May 19 2006
Active Locations (17)
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1
Investigator
Long Beach, California, United States, 90822
2
Investigator
Riverside, California, United States, 92501
3
Investigator
San Diego, California, United States, 92121
4
Investigator
San Francisco, California, United States, 94121