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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intermittent Claudication Peripheral Vascular Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NM-702 tablets intermittent claudication peripheral arterial vascular peripheral arterial disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NM-702 (phosphodiesterase inhibitor)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-IC-0201

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

NM-702 (phosphodiesterase inhibitor)

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nissan Chemical Industries

Locations

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Investigator

Countries

Other Identifiers

NCI-IC-0201