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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102050

Enrollment

390

Registered

2005-01-20

Start date

2003-04-30

Completion date

2006-04-30

Last updated

2006-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication, Peripheral Vascular Disease

Keywords

NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease

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 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

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.

Interventions

DRUGNM-702 (phosphodiesterase inhibitor)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Improvement in peak walking time at 24 weeks	—

Secondary

Measure	Time frame
Health status survey questionnaire	—
Improvement in claudication onset time at 24 weeks	—
Walking impairment questionnaire	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026