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NCT Number: NCT00102050

Efficacy and Safety of NM-702 Tablets 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 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.

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Key information

Conditions

Intermittent Claudication Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator, Long Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NM-702 (phosphodiesterase inhibitor)

Drug

Primary outcomes

  1. Improvement in peak walking time at 24 weeks

Secondary outcomes

  1. Improvement in claudication onset time at 24 weeks

  2. Health status survey questionnaire

  3. Walking impairment questionnaire

Sponsors and collaborators

Lead sponsor

Nissan Chemical Industries

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Jan 20, 2005
Registry last updated
May 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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