Trial · NCT01280266
Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
NCT01280266, Phase 2, Phase 3, Completed, Seoul National University Hospital; results first posted 2012-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon. Trials, record NCT01280266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01280266
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon
- NCT number
- NCT01280266
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 29 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Raynaud Phenomenon
- Interventions
- Udenafil or Amlodipine
- First posted
- 2011-01-20
- Last updated
- 2012-12-11
- Results first posted
- 2012-12-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RP Attacks Per Day | baselin and 4 weeks | Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited. |
| Secondary | Change in Raynaud's Condition Score (RCS) | baseline and 4 weeks | change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20). Range 0-10 ordinal scale 0..good 10.. bad |
| Secondary | Change in the RP Duration | baseline and 4 weeks | Change in the average RP duration in minutes (min) per attack. 0 -- unlimited |
| Secondary | Change in Health Assessment Questionnaire (HAQ) | 0 and 4 weeks | Ordinal scale 0-10 0 good 10 bad |
| Secondary | Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | at 0 (baseline) and 4 weeks (after treatment) | Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline. negative value (decrease in value) means improvement. |
| Secondary | Change in Digital Ulcer Number | baseline and 4 weeks | 0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline. |
| Secondary | Change in Peak Systolic Flow (cm/Sec) | baseline and 4 weeks | Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited |
| Secondary | Time-averaged Peak Velocity (cm/Sec) | baseline and 4 weeks | changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited. |
| Secondary | Dorsal-digital-difference. | baseline and 4 weeks | The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | RP Attacks Per Day | baselin and 4 weeks | 14 patients in UA arm + 12 patients in AU arm | attacks per day | MEAN |
| SECONDARY | Change in Raynaud's Condition Score (RCS) | baseline and 4 weeks | units on a scale | MEAN | |
| SECONDARY | Change in the RP Duration | baseline and 4 weeks | min per attack | MEAN | |
| SECONDARY | Change in Health Assessment Questionnaire (HAQ) | 0 and 4 weeks | units on a scale | MEAN | |
| SECONDARY | Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | at 0 (baseline) and 4 weeks (after treatment) | units on a scale | MEAN | |
| SECONDARY | Change in Digital Ulcer Number | baseline and 4 weeks | Digital ulcers | MEAN | |
| SECONDARY | Change in Peak Systolic Flow (cm/Sec) | baseline and 4 weeks | cm/sec | MEAN | |
| SECONDARY | Time-averaged Peak Velocity (cm/Sec) | baseline and 4 weeks | cm/sec | MEAN | |
| SECONDARY | Dorsal-digital-difference. | baseline and 4 weeks | degree celcius. | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| RP Attacks Per Day | Amlodipine | -0.5 | Standard Deviation 1.4 | attacks per day | |
| RP Attacks Per Day | Udenafil | -0.5 | Standard Deviation 0.9 | attacks per day | |
| Change in Raynaud's Condition Score (RCS) | Amlodipine | -0.5 | Standard Deviation 1.5 | units on a scale | |
| Change in Raynaud's Condition Score (RCS) | Udenafil | -0.3 | Standard Deviation 1.0 | units on a scale | |
| Change in the RP Duration | Amlodipine | -1.1 | Standard Deviation 5.9 | min per attack | |
| Change in the RP Duration | Udenafil | -1.4 | Standard Deviation 11.4 | min per attack | |
| Change in Health Assessment Questionnaire (HAQ) | Amlodipine | 0.1 | Standard Deviation 0.4 | units on a scale | |
| Change in Health Assessment Questionnaire (HAQ) | Udenafil | -0.1 | Standard Deviation 0.3 | units on a scale | |
| Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | Amlodipine | -0.9 | Standard Deviation 1.4 | units on a scale | |
| Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | Udenafil | -1.5 | Standard Deviation 1.6 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (Week 1-4) | STARTED | Amlodipine-Udenafil (AU) Arm | 15 | |
| First Intervention (Week 1-4) | STARTED | Udenafil-Amlodipine (UA) Arm | 14 | |
| First Intervention (Week 1-4) | COMPLETED | Amlodipine-Udenafil (AU) Arm | 14 | |
| First Intervention (Week 1-4) | COMPLETED | Udenafil-Amlodipine (UA) Arm | 12 | |
| First Intervention (Week 1-4) | NOT COMPLETED | Amlodipine-Udenafil (AU) Arm | 1 | |
| First Intervention (Week 1-4) | NOT COMPLETED | Udenafil-Amlodipine (UA) Arm | 2 | |
| Washout Period (Week 4-5) | STARTED | Amlodipine-Udenafil (AU) Arm | 14 | |
| Washout Period (Week 4-5) | STARTED | Udenafil-Amlodipine (UA) Arm | 12 | |
| Washout Period (Week 4-5) | COMPLETED | Amlodipine-Udenafil (AU) Arm | 14 | |
| Washout Period (Week 4-5) | COMPLETED | Udenafil-Amlodipine (UA) Arm | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Facial flushing | General disorders | Amlodipine | 8 | 26 | 8 |
| other | Facial flushing | General disorders | Udenafil | 13 | 26 | 13 |
| other | Facial edema | General disorders | Amlodipine | 4 | 26 | 4 |
| other | Facial edema | General disorders | Udenafil | 10 | 26 | 10 |
| other | Peripheral edema | General disorders | Amlodipine | 4 | 26 | 4 |
| other | Peripheral edema | General disorders | Udenafil | 6 | 26 | 6 |
| other | Headache | General disorders | Amlodipine | 3 | 26 | 3 |
| other | Headache | General disorders | Udenafil | 3 | 26 | 3 |
| other | Blurred vision | Eye disorders | Amlodipine | 2 | 26 | 2 |
| other | Blurred vision | Eye disorders | Udenafil | 2 | 26 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine | ||
| Total, all-cause mortality | Udenafil | ||
| Total, other adverse events | Amlodipine | 14 | 26 |
| Total, other adverse events | Udenafil | 19 | 26 |
| Total, serious adverse events | Amlodipine | 0 | 26 |
| Total, serious adverse events | Udenafil | 2 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24352340 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amlodipine vs Udenafil: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01280266
GET https://conductscience.org/api/trials/v1/NCT01280266/events?page=2