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

Phase 2CompletedNCT00102050

Nissan Chemical Industries390 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

390

Conditions

Intermittent Claudication Peripheral Vascular Disease

Interventions

NM-702 (phosphodiesterase inhibitor)DRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (17)

Investigator

Long Beach, California, United States

Investigator

Riverside, California, United States

Investigator

Outcomes

Primary Outcomes

Improvement in peak walking time at 24 weeks

Secondary Outcomes

Improvement in claudication onset time at 24 weeks

Health status survey questionnaire

Walking impairment questionnaire

Data from ClinicalTrials.gov

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