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The purpose of this study is to evaluate the safety and efficacy of K-134 for the treatment of intermittent claudication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose K-134 | Experimental |
| |
| mid dose K-134 | Experimental |
| |
| high dose K-134 | Experimental |
| |
| Comparator | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-134 | Drug | K-134 is given as low dose mid dose and high dose tablets for 26 Weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in peak walking time at 26 weeks | 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in claudication onset time at 26 weeks | 26 Weeks |
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Inclusion Criteria:
- Stable claudication symptoms
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Morgan, M.D., FACS | Kowa Research Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21612611 | Derived | 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. |
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| Cilostazol 100 mg BID | Drug | Cilostazol 100mg BID for 26 weeks. |
|
| Placebo | Drug | Placebo BID for 26 weeks. |
|
| Little Rock |
| Arkansas |
| United States |
| Beverly Hills | California | United States |
| Los Angeles | California | United States |
| Sacramento | California | United States |
| Santa Rosa | California | United States |
| Vista | California | United States |
| Aurora | Colorado | United States |
| Clearwater | Florida | United States |
| Gulf Breeze | Florida | United States |
| Hialeah | Florida | United States |
| Jacksonville | Florida | United States |
| Pensacola | Florida | United States |
| Sarasota | Florida | United States |
| St. Petersburg | Florida | United States |
| Aurora | Illinois | United States |
| Chicago | Illinois | United States |
| Hinsdale | Illinois | United States |
| Indianapolis | Indiana | United States |
| Auburn | Maine | United States |
| St Louis | Missouri | United States |
| Oklahoma City | Oklahoma | United States |
| Danville | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Charleston | South Carolina | United States |
| Amarillo | Texas | United States |
| Houston | Texas | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Madison | Wisconsin | United States |
| Gatchina | Russia |
| Irkutsk | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Pskov | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Smolensk | Russia |
| Sochi | Russia |
| Tomsk | Russia |
| Volgograd | Russia |
| Yaroslavl | Russia |
| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C116725 | OPC 33509 |
| D000077407 | Cilostazol |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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