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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intermittent Claudication, Peripheral Vascular Disease

Intervention / Treatment
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* Drug: NM-702 (phosphodiesterase inhibitor)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NM-702 (phosphodiesterase inhibitor)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in peak walking time at 24 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in claudication onset time at 24 weeks |  |  | 
| Health status survey questionnaire |  |  | 
| Walking impairment questionnaire |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease