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Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

Raynaud's Disease Clinical Trial

Official title:
A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.

Clinical Trial Summary

To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

Clinical Trial Description

1. Number and cumulative duration of Raynaud's attacks. 2. Adverse events and changes in vital signs. 3. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00528242
Study type Interventional
Source Response Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date June 2007
Completion date March 2008
View Details
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