CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 29 enrolled
Drug / intervention
Udenafil or Amlodipinedrug
Likely dose
Udenafil or Amlodipine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01280266
NCT01280266Phase 3Completed
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Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial

Seoul National University Hospital·interventional·Posted Jan 20, 2011·Updated Dec 11, 2012

In Brief

A Phase 3 clinical trial evaluating Udenafil or Amlodipine for Raynaud Phenomenon. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRaynaud Phenomenon
CountriesSouth Korea
CollaboratorsDong-A Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.5 years ago

Interventions

Udenafil or Amlodipinedrug

Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily