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

Phase

2/3

Condition

Lupus

Circulation Disorders

Scleroderma

Treatment

N/A

Clinical Study ID

NCT01280266

RaynaudSNUH

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

secondary Raynaud's phenomenon

Exclusion

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 coronaryartery bypass surgery
hypotension (less than 90/50 mmHg) or uncontrolled hypertension

Study Design

January 01, 2011

June 30, 2011

Connect with a study center

Seoul National University Hospital
Seoul, 110-744
Korea, Republic of
Site Not Available

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