NCT00102050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 19, 2006

Status Verified

May 1, 2006

First QC Date

January 19, 2005

Last Update Submit

May 17, 2006

Conditions

Intermittent ClaudicationPeripheral Vascular Disease

Keywords

NM-702 tabletsintermittent claudicationperipheralarterialvascularperipheral arterial disease

Outcome Measures

Primary Outcomes (1)

  • Improvement in peak walking time at 24 weeks

Secondary Outcomes (3)

  • Improvement in claudication onset time at 24 weeks

  • Health status survey questionnaire

  • Walking impairment questionnaire

Interventions

NM-702 (phosphodiesterase inhibitor)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
  • Median treadmill peak walking time between 90 and 600 seconds

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Investigator

Long Beach, California, 90822, United States

Location

Investigator

Riverside, California, 92501, United States

Location

Investigator

San Diego, California, 92121, United States

Location

Investigator

San Francisco, California, 94121, United States

Location

Investigator

Torrance, California, 90502, United States

Location

Investigator

Clearwater, Florida, 33761, United States

Location

Investigator

Coral Gables, Florida, 33134, United States

Location

Investigator

Jacksonville, Florida, 32216, United States

Location

Investigator

Springfield, Illinois, 62702, United States

Location

Investigator

Shawnee Mission, Kansas, 66204, United States

Location

Investigator

New Orleans, Louisiana, 70124, United States

Location

Investigator

New York, New York, 10003, United States

Location

Investigator

Durham, North Carolina, 27705, United States

Location

Investigator

Toledo, Ohio, 43606, United States

Location

Investigator

Warwick, Rhode Island, 02886, United States

Location

Investigator

San Antonio, Texas, 43606, United States

Location

Investigator

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Intermittent ClaudicationPeripheral Vascular DiseasesPeripheral Arterial Disease

Interventions

4-bromo-6-(3-(4-chlorophenyl)propoxy)-5-(3-pyridylmethylamino)-3(2H)-pyridazinone hydrochloridePhosphodiesterase Inhibitors

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2005

First Posted

January 20, 2005

Study Start

April 1, 2003

Study Completion

April 1, 2006

Last Updated

May 19, 2006

Record last verified: 2006-05

Locations

US(17)