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| Name | Class |
|---|---|
| Dong-A Pharmaceutical Co., Ltd. | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amlodipine-Udenafil (AU) arm | Experimental | Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks |
|
| Udenafil-Amlodipine (UA) arm | Experimental | Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil or Amlodipine | Drug | Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| RP Attacks Per Day | Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited. | baselin and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Raynaud's Condition Score (RCS) | 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 | baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eun Bong Lee, MD PhD | professor of Seoul National University College of Medicine | Principal Investigator |
| Eun Young Lee, MD PhD | Assistant professor, Seoul National University College of Medicine | Study Director |
| Jin Kyun Park, MD | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24352340 | Derived | Lee EY, Park JK, Lee W, Kim YK, Park CS, Giles JT, Park JW, Shin K, Lee JS, Song YW, Lee EB. Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud's phenomenon: a double-blind, randomized, cross-over study. Rheumatology (Oxford). 2014 Apr;53(4):658-64. doi: 10.1093/rheumatology/ket417. Epub 2013 Dec 17. |
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30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.
Recruitment begin Jan 13 2011 until Mar 15 2011. Location: Rheumatology outpatient clinic at Seoul National University Hospital, Seoul, Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine-Udenafil (AU) Arm | Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks. |
| FG001 | Udenafil-Amlodipine (UA) Arm | Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Week 1-4) |
|
| |||||||||||||||||||||
| Washout Period (Week 4-5) |
| ||||||||||||||||||||||
| Second Intervention (Week 5-9) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine-Udenafil (AU) Arm | Amlodipine first, then Udenafil |
| BG001 | Udenafil-Amlodipine (UA) Arm | Udenafil first, then Amlodipine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RP Attacks Per Day | Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited. | 14 patients in UA arm + 12 patients in AU arm | Posted | Mean | Standard Deviation | attacks per day | baselin and 4 weeks |
|
During 8 weeks while taking a study drug.
As a cross over trial, study participants received both amlodipine and udenafil following each other.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amlodipine | Adverse effects observed while taking amlodipine in both study arms |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial edema | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial flushing | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eun Bong Lee | Seoul National University | +82 2 2072-3944 | leb7616@snu.ac.kr |
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| ID | Term |
|---|---|
| D011928 | Raynaud Disease |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C419664 | udenafil |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Change in the RP Duration | Change in the average RP duration in minutes (min) per attack. 0 -- unlimited | baseline and 4 weeks |
| Change in Health Assessment Questionnaire (HAQ) | Ordinal scale 0-10 0 good 10 bad | 0 and 4 weeks |
| Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | 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. | at 0 (baseline) and 4 weeks (after treatment) |
| Change in Digital Ulcer Number | 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. | baseline and 4 weeks |
| Change in Peak Systolic Flow (cm/Sec) | Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited | baseline and 4 weeks |
| Time-averaged Peak Velocity (cm/Sec) | changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited. | baseline and 4 weeks |
| Dorsal-digital-difference. | The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius. | baseline and 4 weeks |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease subtype | Underlying rheumatic disease | Number | participant |
|
| RP duration | Mean | Standard Deviation | years |
|
| Prior use of vasodilator | Number | Participant |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Raynaud's Condition Score (RCS) | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline and 4 weeks |
|
|
|
| Secondary | Change in the RP Duration | Change in the average RP duration in minutes (min) per attack. 0 -- unlimited | Posted | Mean | Standard Deviation | min per attack | baseline and 4 weeks |
|
|
|
| Secondary | Change in Health Assessment Questionnaire (HAQ) | Ordinal scale 0-10 0 good 10 bad | Posted | Mean | Standard Deviation | units on a scale | 0 and 4 weeks |
|
|
|
| Secondary | Change in Physician's Global Assessment on Visual Analogue Scale (VAS) | 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. | Posted | Mean | Standard Deviation | units on a scale | at 0 (baseline) and 4 weeks (after treatment) |
|
|
|
| Secondary | Change in Digital Ulcer Number | 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. | Posted | Mean | Standard Deviation | Digital ulcers | baseline and 4 weeks |
|
|
|
| Secondary | Change in Peak Systolic Flow (cm/Sec) | Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited | Posted | Mean | Standard Deviation | cm/sec | baseline and 4 weeks |
|
|
|
| Secondary | Time-averaged Peak Velocity (cm/Sec) | changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited. | Posted | Mean | Standard Deviation | cm/sec | baseline and 4 weeks |
|
|
|
| Secondary | Dorsal-digital-difference. | The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius. | Posted | Mean | Standard Deviation | degree celcius. | baseline and 4 weeks |
|
|
|
| 0 |
| 26 |
| 14 |
| 26 |
| EG001 | Udenafil | Adverse effects observed while taking udenafil in both study arms | 2 | 26 | 19 | 26 |
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Facial edema | General disorders | Non-systematic Assessment |
|
| Peripheral edema | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Blurred vision | Eye disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Epistaxis | General disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Throat irritation | General disorders | Non-systematic Assessment |
|
| Zoster | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |