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

Seoul National University logo

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

29 participants in 2 patient groups

Amlodipine-Udenafil (AU) arm
Experimental group
Description:
Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
Treatment:
Drug: Udenafil or Amlodipine
Udenafil-Amlodipine (UA) arm
Experimental group
Description:
Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
Treatment:
Drug: Udenafil or Amlodipine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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