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

Seoul National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Raynaud Phenomenon

Treatments

Drug: Udenafil or Amlodipine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01280266

RaynaudSNUH

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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