Trial | NCT00102050  Report issue

Title

Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Parogrelil ...

  • Study Participants

    390
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.
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 Started
Apr 30
2003
Study Completion
Apr 30
2006
Last Update
May 19
2006
Estimate

Drug NM-702 (phosphodiesterase inhibitor)

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.
No Results Posted