Phase 3
N=29
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
Raynaud Phenomenon
Bottom Line
View on ClinicalTrials.gov: NCT01280266 ↗Enrolled (actual)
29
Serious AEs
3.9%
Results posted
Dec 2012
Primary outcome: Primary: RP Attacks Per Day — -0.5; -0.5 attacks per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Udenafil or Amlodipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RP Attacks Per Day |
-0.5; -0.5 | — |
| SECONDARY Change in Raynaud's Condition Score (RCS) |
-0.5; -0.3 | — |
| SECONDARY Change in the RP Duration |
-1.1; -1.4 | — |
| SECONDARY Change in Health Assessment Questionnaire (HAQ) |
0.1; -0.1 | — |
| SECONDARY Change in Physician's Global Assessment on Visual Analogue Scale (VAS) |
-0.9; -1.5 | — |
| SECONDARY Change in Digital Ulcer Number |
0.1; 0.1 | — |
| SECONDARY Change in Peak Systolic Flow (cm/Sec) |
-19.9; 63.2 | — |
| SECONDARY Time-averaged Peak Velocity (cm/Sec) |
-17.3; 33.4 | — |
| SECONDARY Dorsal-digital-difference. |
-0.7; -1.4 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01280266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.