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

January 19, 2005
May 17, 2006
April 2003
Not Provided
Improvement in peak walking time at 24 weeks
Same as current
Complete list of historical versions of study NCT00102050 on ClinicalTrials.gov Archive Site
  • Improvement in claudication onset time at 24 weeks
  • Health status survey questionnaire
  • Walking impairment questionnaire
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Intermittent Claudication
  • Peripheral Vascular Disease
Drug: NM-702 (phosphodiesterase inhibitor)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
April 2006
Not Provided

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102050
NCI-IC-0201
Not Provided
Not Provided
Nissan Chemical Industries
Not Provided
Not Provided
Nissan Chemical Industries
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP