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

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ClinicalTrials.gov Identifier: NCT01280266
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Raynaud Phenomenon
Intervention Drug: Udenafil or Amlodipine
Enrollment 29
Recruitment Details Recruitment begin Jan 13 2011 until Mar 15 2011. Location: Rheumatology outpatient clinic at Seoul National University Hospital, Seoul, Korea.
Pre-assignment Details 30 Patients were initially recruited, but an error occurred in obtaining informed consent and this one was withdrawn.
Arm/Group Title Amlodipine-Udenafil (AU) Arm Udenafil-Amlodipine (UA) Arm
Hide Arm/Group Description Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks. Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
Period Title: First Intervention (Week 1-4)
Started 15 14
Completed 14 12
Not Completed 1 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             0             2
Period Title: Washout Period (Week 4-5)
Started 14 12
Completed 14 12
Not Completed 0 0
Period Title: Second Intervention (Week 5-9)
Started 14 12
Completed 14 12
Not Completed 0 0
Arm/Group Title Amlodipine-Udenafil (AU) Arm Udenafil-Amlodipine (UA) Arm Total
Hide Arm/Group Description Amlodipine first, then Udenafil Udenafil first, then Amlodipine Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
12
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
49.6  (14.0) 52.3  (10.3) 50.9  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
13
  92.9%
11
  91.7%
24
  92.3%
Male
1
   7.1%
1
   8.3%
2
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 14 participants 12 participants 26 participants
14 12 26
Disease subtype   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 14 participants 12 participants 26 participants
Localized systemic sclerosis (SSc) 1 2 3
diffuse SSc 10 7 17
Mixed connective tissue disease 1 2 3
Sjogren's disease 2 1 3
[1]
Measure Description: Underlying rheumatic disease
RP duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
8.8  (8.7) 5.6  (2.3) 7.3  (6.6)
Prior use of vasodilator  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 14 participants 12 participants 26 participants
calcium channel blocker 1 4 5
angiotensin receptor blocker 2 0 2
Pentyxifylline 1 1 2
No prior use 10 7 17
1.Primary Outcome
Title RP Attacks Per Day
Hide Description Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.
Time Frame baselin and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
14 patients in UA arm + 12 patients in AU arm
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Changes in RP attacks per day during amlodipine 10 mg orally per day
Changes in RP attacks per day during udenafil 100mg orally per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: attacks per day
-0.5  (1.4) -0.5  (0.9)
2.Secondary Outcome
Title Change in Raynaud's Condition Score (RCS)
Hide Description

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

Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Changes in RPS during amlodipine 100 mg orally per day
Changes in RPS during udenafil 10 mg orally per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (1.5) -0.3  (1.0)
3.Secondary Outcome
Title Change in the RP Duration
Hide Description Change in the average RP duration in minutes (min) per attack. 0 -- unlimited
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: min per attack
-1.1  (5.9) -1.4  (11.4)
4.Secondary Outcome
Title Change in Health Assessment Questionnaire (HAQ)
Hide Description Ordinal scale 0-10 0 good 10 bad
Time Frame 0 and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (0.4) -0.1  (0.3)
5.Secondary Outcome
Title Change in Physician's Global Assessment on Visual Analogue Scale (VAS)
Hide Description

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.

Time Frame at 0 (baseline) and 4 weeks (after treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.4) -1.5  (1.6)
6.Secondary Outcome
Title Change in Digital Ulcer Number
Hide Description 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.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: Digital ulcers
0.1  (0.4) 0.1  (0.3)
7.Secondary Outcome
Title Change in Peak Systolic Flow (cm/Sec)
Hide Description

Change in digital artery flow velocity in proper palmar digital artery in cm/sec.

0-unlimited

Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: cm/sec
-19.9  (145.9) 63.2  (170.2)
8.Secondary Outcome
Title Time-averaged Peak Velocity (cm/Sec)
Hide Description changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: cm/sec
-17.3  (98.6) 33.4  (123)
9.Secondary Outcome
Title Dorsal-digital-difference.
Hide Description The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description:
Drug: amlodipine 100 mg p.o. per day
Drug: udenafil 10 mg p.o. per day
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: degree celcius.
-0.7  (3.2) -1.4  (3.3)
Time Frame During 8 weeks while taking a study drug.
Adverse Event Reporting Description As a cross over trial, study participants received both amlodipine and udenafil following each other.
 
Arm/Group Title Amlodipine Udenafil
Hide Arm/Group Description Adverse effects observed while taking amlodipine in both study arms Adverse effects observed while taking udenafil in both study arms
All-Cause Mortality
Amlodipine Udenafil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Amlodipine Udenafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      2/26 (7.69%)    
General disorders     
Facial edema   0/26 (0.00%)  0 1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders     
Myalgia *  0/26 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Amlodipine Udenafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/26 (53.85%)      19/26 (73.08%)    
Congenital, familial and genetic disorders     
Zoster *  1/26 (3.85%)  1 0/26 (0.00%)  0
Eye disorders     
Blurred vision   2/26 (7.69%)  2 2/26 (7.69%)  2
General disorders     
Facial flushing   8/26 (30.77%)  8 13/26 (50.00%)  13
Facial edema *  4/26 (15.38%)  4 10/26 (38.46%)  10
Peripheral edema *  4/26 (15.38%)  4 6/26 (23.08%)  6
Headache   3/26 (11.54%)  3 3/26 (11.54%)  3
Epistaxis *  1/26 (3.85%)  1 0/26 (0.00%)  0
Dry mouth *  1/26 (3.85%)  1 0/26 (0.00%)  0
Throat irritation *  1/26 (3.85%)  1 0/26 (0.00%)  0
Nervous system disorders     
Paresthesia *  3/26 (11.54%)  3 1/26 (3.85%)  1
Skin and subcutaneous tissue disorders     
Pruritus *  1/26 (3.85%)  1 2/26 (7.69%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eun Bong Lee
Organization: Seoul National University
Phone: +82 2 2072-3944
EMail: leb7616@snu.ac.kr
Layout table for additonal information
Responsible Party: Eun Bong Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01280266    
Other Study ID Numbers: RaynaudSNUH
First Submitted: January 14, 2011
First Posted: January 20, 2011
Results First Submitted: July 4, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012