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

This study has been completed.
Sponsor:
Information provided by:
Nissan Chemical Industries
ClinicalTrials.gov Identifier:
NCT00102050
First received: January 19, 2005
Last updated: May 17, 2006
Last verified: May 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Nissan Chemical Industries:

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

Estimated Enrollment: 390
Study Start Date: April 2003
Estimated Study Completion Date: April 2006
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102050

Locations
United States, California
Investigator
Long Beach, California, United States, 90822
Investigator
Riverside, California, United States, 92501
Investigator
San Diego, California, United States, 92121
Investigator
San Francisco, California, United States, 94121
Investigator
Torrance, California, United States, 90502
United States, Florida
Investigator
Clearwater, Florida, United States, 33761
Investigator
Coral Gables, Florida, United States, 33134
Investigator
Jacksonville, Florida, United States, 32216
United States, Illinois
Investigator
Springfield, Illinois, United States, 62702
United States, Kansas
Investigator
Shawnee Mission, Kansas, United States, 66204
United States, Louisiana
Investigator
New Orleans, Louisiana, United States, 70124
United States, New York
Investigator
New York, New York, United States, 10003
United States, North Carolina
Investigator
Durham, North Carolina, United States, 27705
United States, Ohio
Investigator
Toledo, Ohio, United States, 43606
United States, Rhode Island
Investigator
Warwick, Rhode Island, United States, 02886
United States, Texas
Investigator
San Antonio, Texas, United States, 43606
United States, Washington
Investigator
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Nissan Chemical Industries
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102050     History of Changes
Other Study ID Numbers: NCI-IC-0201
Study First Received: January 19, 2005
Last Updated: May 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Nissan Chemical Industries:
NM-702 tablets
intermittent claudication
peripheral
arterial
vascular
peripheral arterial disease

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Signs and Symptoms
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 30, 2014