Novel investigational therapy for the treatment of intermittent claudication for those who suffer from Peripheral Arterial Disease (PAD).

The purpose of this study is to evaluate the efficacy of a potent new PDE inhibitor in those who experience intermittent claudication as a result of Peripheral Arterial Disease (PAD). There will be approximately 200 to 400 patients recruited for this study.  At Rush University Medical Center we expect to recruit approximately 10 patients.  The treatment will be assigned randomly. 

You may be eligible for this study if you:

• Are 40 years of age or older
• Have a diagnosis of intermittent claudication secondary to atherosclerosis, confirmed by history and on of the following observed in either leg
  • Resting ABI of .90 or less at screening
  • Resting ABI greater than 0.90 and less than or equal to 1.00 with a reduction of 0.20 or more in ABI when measured within one minute after treadmill exercise at screening
• Have claudication symptoms and severity stable for at least three months prior to screening

You will be excluded from this study if you:

1. Have lower extremity amputation which interferes with walking on the treadmill
2. Have had a percutaneous revascularization procedure within 3 months prior to screening
3. Have had CABG, open peripheral vascular procedures, or major surgical procedures within the 6 months prior to screening
4. Have a history of CHF or presence of CHF
5. Have had a MI within 4 months prior to screening