CompletedPhase 2/3

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

South Korea29 participantsStarted 2011-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

RP Attacks Per Day

Timeframe: baselin and 4 weeks

Trial details

NCT IDNCT01280266

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-05

Results submitted2012-07-04

View on ClinicalTrials.gov More Raynaud Phenomenon trials