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 ]

The Raynaud's Condition Score (RCS) is a clinically validated scale used to determine the difficulty that patients experience with Raynaud's phenomenon, and is closely associated with the measures of disability and overall impact and activity of the disease.


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