Trial Information

Summary: A six-month study using an FDA approved high blood pressure medication to evaluate its usefulness in lower leg circulation problems (intermittent claudication)

This is a six-month Phase IV single-center study designed to assess the effectiveness of an FDA approved oral drug for high blood pressure (Trade name - Cozaar / generic name - losartan potassium) in treating patients with peripheral arterial disease due to atherosclerosis.

The trial is seeking patients with mild to moderated leg pain brought on by exercise and relieved by rest (intermittent claudication). Visits will occur every 6-8 weeks over a 24-week period.

All patients will receive oral losartan as the study medication. It is taken once a day with an initial dose of 50 mgm, and, if tolerated well and your blood pressure is stable, the dose will be increased to 100 mgm per day. Safety will be monitored throughout the study period with regular lab work and physical exams. Further study in the format of a double-blinded randomized (with a placebo or inactive control) trial will be pursued if results of this pilot study suggest that patients with intermittent claudication may benefit.

You may be eligible for this study if you have none of the exclusions and have all the entry conditions for this trial. The major criteria are:

• Over age of 40
• Chronic, stable, mild to moderate intermittent claudication of at least six months duration (diagnosed with peripheral artery disease);
• Be in overall good health, with well-controlled blood pressure and/or heart failure, and minimal liver or kidney problems;
• Be able to walk on a treadmill for at least several minutes, stopping only due to leg pain or cramping due to claudication;
• No rest pain, non-healing wounds on the toes or feet, or gangrene;
• May not be taking Trental (pentoxifylline), Plendil (clipidogrel), or certain other drugs;

Be available for approximately 8-10 clinic visits.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 1, 2008 at 5:43:15 AM