Intermittent ClaudicationPhase 2NCT00783081
Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
A Phase 2 study testing K-134 and Cilostazol 100 mg BID in people with Intermittent Claudication, run by Kowa Research Institute, Inc. at 42 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- K-134 and Cilostazol 100 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- 42 sitesin 2 countries
- Study dates
- Nov 2008to Jul 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable claudication symptoms
Who cannot join
- Lower extremity amputation
- Signs or symptoms of critical leg ischemia (CLI)
- Uncontrolled hypertension
- Tachycardia
- Poorly controlled diabetes
- Hypercholesterolemia
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States30 sites
Study site
Amarillo, Texas
Study site
Auburn, Maine
Study site
Aurora, Colorado
Study site
Aurora, Illinois
Study site
Beverly Hills, California
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Clearwater, Florida
Study site
Danville, Pennsylvania
Study site
Gulf Breeze, Florida
Study site
Hialeah, Florida
Study site
Hinsdale, Illinois
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Pensacola, Florida
Study site
Richmond, Virginia
Study site
Sacramento, California
Study site
Santa Rosa, California
Study site
Sarasota, Florida
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Tucson, Arizona
Study site
Vista, California
Study site
Warwick, Rhode Island
Russia12 sites
Study site
Gatchina
Study site
Irkutsk
Study site
Moscow
Study site
Novosibirsk
Study site
Pskov
Study site
Saint Petersburg
Study site
Saratov
Study site
Smolensk
Study site
Sochi
Study site
Tomsk
Study site
Volgograd
Study site
Yaroslavl
About this study
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
- Conditions
- Intermittent Claudication
- Being tested
- K-134, Cilostazol 100 mg BID, Placebo
- Keywords
- Intermittent Claudication, Peripheral Arterial Disease
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-134Drug
K-134 is given as low dose mid dose and high dose tablets for 26 Weeks.
Cilostazol 100 mg BIDDrug
Cilostazol 100mg BID for 26 weeks.
PlaceboDrug
Placebo BID for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| low dose K-134 | Experimental | Not described Receives: Drug: K-134 |
| mid dose K-134 | Experimental | Not described Receives: Drug: K-134 |
| high dose K-134 | Experimental | Not described Receives: Drug: K-134 |
| Comparator | Active comparator | Not described Receives: Drug: Cilostazol 100 mg BID |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in peak walking time at 26 weeks
Measured: 26 Weeks
Secondary outcomes (1)
Improvement in claudication onset time at 26 weeks
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Morgan, M.D., FACS, Study director, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783081
- Sponsor's protocol ID
- K-134-2.01US
- Status last verified
- Mar 2012
- First submitted
- 30 Oct 2008
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lewis RJ, Connor JT, Teerlink JR, Murphy JR, Cooper LT, Hiatt WR, Brass EP. Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication. Trials. 2011 May 25;12:134. doi: 10.1186/1745-6215-12-134.
PubMed 21612611
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of K-134 for the Treatment of Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00783081
- Acronym / sponsor ID
- K-134-2.01US
- Conditions
- Intermittent Claudication
- Keywords
- Intermittent Claudication, Peripheral Arterial Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 Oct 2008 (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.
The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| low dose K-134 | Experimental | Drug: K-134 |
| mid dose K-134 | Experimental | Drug: K-134 |
| high dose K-134 | Experimental | Drug: K-134 |
| Comparator | Active comparator | Drug: Cilostazol 100 mg BID |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable claudication symptoms
Key exclusion criteria (6 listed)
- Lower extremity amputation
- Signs or symptoms of critical leg ischemia (CLI)
- Uncontrolled hypertension
- Tachycardia
- Poorly controlled diabetes
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 |
|---|---|---|
| K-134K-134 is given as low dose mid dose and high dose tablets for 26 Weeks. | Drug | high dose K-134, low dose K-134, mid dose K-134 |
| Cilostazol 100 mg BIDCilostazol 100mg BID for 26 weeks. | Drug | Comparator |
| PlaceboPlacebo BID for 26 weeks. | Drug | Placebo |
Primary outcome
Improvement in peak walking time at 26 weeks
Time frame: 26 Weeks
1 secondary outcome
Improvement in claudication onset time at 26 weeks
Time frame: 26 Weeks
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 22 Mar 2012.
- Derived from this study: PubMed 21612611Lewis RJ, Connor JT, Teerlink JR, Murphy JR, Cooper LT, Hiatt WR, Brass EP. Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication. Trials. 2011 May 25;12:134. doi: 10.1186/1745-6215-12-134.
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.
Roger Morgan, M.D., FACS study director
Kowa Research Institute, Inc.
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-134 and Cilostazol 100 mg BID in people with Intermittent Claudication, run by Kowa Research Institute, Inc. at 42 sites in 2 countries.
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 1 inclusion and 6 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 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Russia. 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. Some participants in this study may receive a placebo. 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 26 weeks (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00783081, which also lists 1 linked publication.
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 22 Mar 2012.