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

Primary Purpose

Intermittent Claudication, Peripheral Vascular Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NM-702 (phosphodiesterase inhibitor)
Sponsored by
Nissan Chemical Industries
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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Outcomes

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

Full Information

First Posted
January 19, 2005
Last Updated
May 17, 2006
Sponsor
Nissan Chemical Industries
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1. Study Identification

Unique Protocol Identification Number
NCT00102050
Brief Title
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

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Nissan Chemical Industries

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Peripheral Vascular Disease
Keywords
NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
390 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NM-702 (phosphodiesterase inhibitor)
Primary Outcome Measure Information:
Title
Improvement in peak walking time at 24 weeks
Secondary Outcome Measure Information:
Title
Improvement in claudication onset time at 24 weeks
Title
Health status survey questionnaire
Title
Walking impairment questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Investigator
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Investigator
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Investigator
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Investigator
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Investigator
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Investigator
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Investigator
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigator
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigator
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Investigator
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Investigator
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
Investigator
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Investigator
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Investigator
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Investigator
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Investigator
City
San Antonio
State/Province
Texas
ZIP/Postal Code
43606
Country
United States
Facility Name
Investigator
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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