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NCT Number: NCT01280266

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

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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Key information

Conditions

Raynaud Phenomenon Cardiovascular Diseases Embolism and Thrombosis Livedoid Vasculopathy Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Raynaud Disease Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Udenafil or Amlodipine

Drug

Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

Primary outcomes

  1. RP Attacks Per Day

    Time frame: baselin and 4 weeks

    Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.

Secondary outcomes

  1. Change in Raynaud's Condition Score (RCS)

    Time frame: 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

  2. Change in the RP Duration

    Time frame: baseline and 4 weeks

    Change in the average RP duration in minutes (min) per attack. 0 -- unlimited

  3. Change in Health Assessment Questionnaire (HAQ)

    Time frame: 0 and 4 weeks

    Ordinal scale 0-10 0 good 10 bad

  4. Change in Physician's Global Assessment on Visual Analogue Scale (VAS)

    Time frame: 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.

  5. Change in Digital Ulcer Number

    Time frame: 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.

  6. Change in Peak Systolic Flow (cm/Sec)

    Time frame: baseline and 4 weeks

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

    0-unlimited

  7. Time-averaged Peak Velocity (cm/Sec)

    Time frame: baseline and 4 weeks

    changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.

  8. Dorsal-digital-difference.

    Time frame: baseline and 4 weeks

    The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

Registry information

Official study title

Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2011
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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