Intermittent ClaudicationPhase 2NCT00102050
Efficacy and Safety of NM-702 Tablets for the Treatment of Intermittent Claudication
A Phase 2 study testing NM-702 (phosphodiesterase inhibitor) in people with Intermittent Claudication and Peripheral Vascular Disease, run by Nissan Chemical Industries at 17 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intermittent Claudication, Peripheral Vascular Disease
- What is being tested?
- NM-702 (phosphodiesterase inhibitor)
- How many people
- 390 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2003to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
- Median treadmill peak walking time between 90 and 600 seconds
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Investigator
Clearwater, Florida, 33761
Investigator
Coral Gables, Florida, 33134
Investigator
Durham, North Carolina, 27705
Investigator
Jacksonville, Florida, 32216
Investigator
Long Beach, California, 90822
Investigator
New Orleans, Louisiana, 70124
Investigator
New York, New York, 10003
Investigator
Riverside, California, 92501
Investigator
San Antonio, Texas, 43606
Investigator
San Diego, California, 92121
Investigator
San Francisco, California, 94121
Investigator
Shawnee Mission, Kansas, 66204
Investigator
Springfield, Illinois, 62702
Investigator
Tacoma, Washington, 98431
Investigator
Toledo, Ohio, 43606
Investigator
Torrance, California, 90502
Investigator
Warwick, Rhode Island, 02886
About this study
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
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.
Read the 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.
- Being tested
- NM-702 (phosphodiesterase inhibitor)
- Keywords
- NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease
- Medical subject headings
- Intermittent Claudication, Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM-702 (phosphodiesterase inhibitor)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2005 (estimated)
- Study startApr 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 390 participants
Sponsor and investigators
- Lead sponsor
- Nissan Chemical Industries
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102050
- Sponsor's protocol ID
- NCI-IC-0201
- Status last verified
- May 2006
- First submitted
- 19 Jan 2005
- Last updated
- 19 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00102050
- Acronym / sponsor ID
- NCI-IC-0201
- Keywords
- NM-702 tablets, intermittent claudication, peripheral, arterial, vascular, peripheral arterial disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- Nissan Chemical IndustriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Apr 2006
- First posted
- 20 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities
- Median treadmill peak walking time between 90 and 600 seconds
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NM-702 (phosphodiesterase inhibitor) | Drug | – |
Primary outcome
Improvement in peak walking time at 24 weeks
3 secondary outcomes
Improvement in claudication onset time at 24 weeks
Health status survey questionnaire
Walking impairment questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2006.
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NM-702 (phosphodiesterase inhibitor) in people with Intermittent Claudication and Peripheral Vascular Disease, run by Nissan Chemical Industries at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in peak walking time at 24 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2006; AzTrials last refreshed its copy on 8 Nov 2026.