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

Peripheral Vascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102050
• Other study ID #: NCI-IC-0201
• Status: Completed
• Phase: Phase 2
• First received: January 19, 2005
• Last updated: May 17, 2006
• Start date: April 2003
• Est. completion date: April 2006

Study information

• Verified date: May 2006
• Source: Nissan Chemical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• NM-702 (phosphodiesterase inhibitor)

Locations

Country	Name	City	State
United States	Investigator	Clearwater	Florida
United States	Investigator	Coral Gables	Florida
United States	Investigator	Durham	North Carolina
United States	Investigator	Jacksonville	Florida
United States	Investigator	Long Beach	California
United States	Investigator	New Orleans	Louisiana
United States	Investigator	New York	New York
United States	Investigator	Riverside	California
United States	Investigator	San Antonio	Texas
United States	Investigator	San Diego	California
United States	Investigator	San Francisco	California
United States	Investigator	Shawnee Mission	Kansas
United States	Investigator	Springfield	Illinois
United States	Investigator	Tacoma	Washington
United States	Investigator	Toledo	Ohio
United States	Investigator	Torrance	California
United States	Investigator	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Nissan Chemical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in peak walking time at 24 weeks
Secondary	Improvement in claudication onset time at 24 weeks
Secondary	Health status survey questionnaire
Secondary	Walking impairment questionnaire