Clinical trial NCT00102050: Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
Official title: A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intermittent Claudication
Peripheral Vascular Disease
Keywords: NM-702 tablets
intermittent claudication
peripheral
arterial
vascular
peripheral arterial disease
Lead sponsor: Nissan Chemical Industries
Sponsor class: INDUSTRY
First posted: 2005-01-20
Enrollment: 390
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Improvement in peak walking time at 24 weeks
Secondary outcomes:
measure: Improvement in claudication onset time at 24 weeks
measure: Health status survey questionnaire
measure: Walking impairment questionnaire
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Investigator
state: California
city: Riverside
country: United States
facility: Investigator
state: California
city: San Diego
country: United States
facility: Investigator
state: California
city: San Francisco
country: United States
facility: Investigator
state: California
city: Torrance
country: United States
facility: Investigator
state: California
city: Clearwater
country: United States
facility: Investigator
state: Florida
city: Coral Gables
country: United States
facility: Investigator
state: Florida
city: Jacksonville
country: United States
facility: Investigator
state: Florida
city: Springfield
country: United States
facility: Investigator
state: Illinois
city: Shawnee Mission
country: United States
facility: Investigator
state: Kansas
city: New Orleans
country: United States
facility: Investigator
state: Louisiana
city: New York
country: United States
facility: Investigator
state: New York
city: Durham
country: United States
facility: Investigator
state: North Carolina
city: Toledo
country: United States
facility: Investigator
state: Ohio
city: Warwick
country: United States
facility: Investigator
state: Rhode Island
city: San Antonio
country: United States
facility: Investigator
state: Texas
city: Tacoma
country: United States
facility: Investigator
state: Washington
Study officials:
References: