Clinical Trial: Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging
Brief Summary: The purpose of this study is to investigate the effectiveness of a drug called ambrisentan, approved by the FDA for use in pulmonary hypertension (a condition where there is increased pressure in the right side of the heart) in scleroderma patients, to see if this medicine may be beneficial in relieving and/or preventing Raynaud's flares in you and other patients like you. This medicine may have some short-term and long-term benefits in persons with scleroderma
Detailed Summary:
Baseline screening-we will screen you with a baseline review of your history, medications and lab values and you will need to get blood drawn for hemoglobin level, liver function panel and blood pregnancy test for females in child bearing age group. Women are advised strongly to use 2 reliable forms of contraception while in this study unless you have had tubal ligation or intrauterine device placement.
You are advised to stop taking medications like nitrates (like nitroglycerin), calcium channel blockers (like nifedipine or amlodipine), angiotensin converting enzyme inhibitors (like lisinopril or enalapril or captopril), angiotensin receptor blockers (like valsartan or candesartan) or phosphodiesterase inhibitors (like Viagra or Revatio) at least 1 week prior to you coming for the first visit for the study and abstain from them during study period unless absolutely necessary.
Please avoid caffeine, smoking and over the counter cold remedies at least 2 days prior to the first visit and during the study period.
You will be asked to go to the Clinical Research Unit( CRU) located on M 51 in Cleveland Clinic main campus to partake in the study and will go back there for subsequent visits at 1 week and then at 12 weeks after having started the study.
This is a placebo-controlled randomized trial where 15 patients will get the active medication and the other 5 will get a placebo (pill with no active ingredient but not harmful to you in any way). This means you have a 3 in 4 (75%) chance of getting the active medication (ambrisentan) versus the placebo- both pills will look exactly the same. This process is called "randomization" and is similar to flipping a coin. The patients getting the active medication versus placebo
Sponsor: Soumya Chatterjee
Current Primary Outcome: Digital Micro-vascular Flow [ Time Frame: Baseline and 12 weeks ]
Original Primary Outcome: To evaluate if Ambrisentan increases digital micro-vascular flow (measured by LDPI) in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to Systemic Sclerosis (SSc). [ Time Frame: 6-12 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The Cleveland Clinic
Dates:
Date Received: February 19, 2010
Date Started: February 2010
Date Completion:
Last Updated: March 22, 2013
Last Verified: March 2013
