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

This study has been completed.
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01280266
First received: January 14, 2011
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Raynaud Phenomenon
Drug: Udenafil or Amlodipine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • RP Attacks Per Day [ Time Frame: baselin and 4 weeks ] [ Designated as safety issue: No ]
    Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.


Secondary Outcome Measures:
  • Change in Raynaud's Condition Score (RCS) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

    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


  • Change in the RP Duration [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    Change in the average RP duration in minutes (min) per attack. 0 -- unlimited

  • Change in Health Assessment Questionnaire (HAQ) [ Time Frame: 0 and 4 weeks ] [ Designated as safety issue: No ]
    Ordinal scale 0-10 0 good 10 bad

  • Change in Physician's Global Assessment on Visual Analogue Scale (VAS) [ Time Frame: at 0 (baseline) and 4 weeks (after treatment) ] [ Designated as safety issue: No ]

    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.


  • Change in Digital Ulcer Number [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Peak Systolic Flow (cm/Sec) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]

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

    0-unlimited


  • Time-averaged Peak Velocity (cm/Sec) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.

  • Dorsal-digital-difference. [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.


Enrollment: 29
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amlodipine-Udenafil (AU) arm
Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
Drug: Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
Experimental: Udenafil-Amlodipine (UA) arm
Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
Drug: Udenafil or Amlodipine
Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280266

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Eun Bong Lee, MD PhD professor of Seoul National University College of Medicine
Study Director: Eun Young Lee, MD PhD Assistant professor, Seoul National University College of Medicine
Study Director: Jin Kyun Park, MD Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eun Bong Lee, Direct, Division of Rheumatology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01280266     History of Changes
Other Study ID Numbers: RaynaudSNUH
Study First Received: January 14, 2011
Results First Received: July 4, 2012
Last Updated: December 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Pathological Conditions
Signs and Symptoms
Blood circulation

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Udenafil
Phosphodiesterase 5 Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014