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

Sponsor

Nissan Chemical Industries (Industry)

Overall Status

Completed

CT.gov ID

NCT00102050

Collaborator

(none)

390

Enrollment

Locations

Duration (Months)

22.9

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Claudication Peripheral Vascular Disease	Drug: NM-702 (phosphodiesterase inhibitor)	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2003

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Improvement in peak walking time at 24 weeks []

Secondary Outcome Measures

Improvement in claudication onset time at 24 weeks []
Health status survey questionnaire []
Walking impairment questionnaire []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator	Long Beach	California	United States	90822
2	Investigator	Riverside	California	United States	92501
3	Investigator	San Diego	California	United States	92121
4	Investigator	San Francisco	California	United States	94121
5	Investigator	Torrance	California	United States	90502
6	Investigator	Clearwater	Florida	United States	33761
7	Investigator	Coral Gables	Florida	United States	33134
8	Investigator	Jacksonville	Florida	United States	32216
9	Investigator	Springfield	Illinois	United States	62702
10	Investigator	Shawnee Mission	Kansas	United States	66204
11	Investigator	New Orleans	Louisiana	United States	70124
12	Investigator	New York	New York	United States	10003
13	Investigator	Durham	North Carolina	United States	27705
14	Investigator	Toledo	Ohio	United States	43606
15	Investigator	Warwick	Rhode Island	United States	02886
16	Investigator	San Antonio	Texas	United States	43606
17	Investigator	Tacoma	Washington	United States	98431