Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.

Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Dong-A Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Phosphodiesterase 5 Inhibitors; Udenafil

Criteria

Inclusion Criteria:

• secondary Raynaud's phenomenon

Exclusion Criteria:

• primary raynaud phenomenon

• active infection

• hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)

• elevated AST/ALT (3 times above the upper normal limit)

• severe renal failure

• patients on nitrite or nitric oxide (NO) donor treatment

• recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery

• hypotension (less than 90/50 mmHg) or uncontrolled hypertension