Clinical Trial: Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With
Brief Summary: The purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud phenomenon.
Detailed Summary:
Sponsor: University of Cologne
Current Primary Outcome: Change in the Raynaud's Condition Score [ Time Frame: daily for 18 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with adverse events as a Measure of Safety and Tolerability [ Time Frame: daily for 18 weeks ]
- Digital blood flow [ Time Frame: at baseline, one hour after drug intake and after six weeks on therapy ]digital blood flow measured with laser doppler
Original Secondary Outcome: Same as current
Information By: University of Cologne
Dates:
Date Received: February 1, 2011
Date Started: November 2006
Date Completion:
Last Updated: February 7, 2011
Last Verified: January 2011