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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 19, 2005
Last Updated Date	May 17, 2006
Start Date ^ICMJE	April 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Improvement in peak walking time at 24 weeks
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00102050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Improvement in claudication onset time at 24 weeks Health status survey questionnaire Walking impairment questionnaire
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
Official Title ^ICMJE	A Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NM-702 in Subjects With Intermittent Claudication
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Intermittent Claudication Peripheral Vascular Disease
Intervention ^ICMJE	Drug: NM-702 (phosphodiesterase inhibitor)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	390
Completion Date	April 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00102050
Other Study ID Numbers ^ICMJE	NCI-IC-0201
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Nissan Chemical Industries
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nissan Chemical Industries
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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