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

NCT01280266 | Completed Phase 2 Results

• 1 other identifier: RaynaudSNUH
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Raynaud Phenomenon

Keywords

Pathological Conditions; Signs and Symptoms; Blood circulation

Outcome Measures

Primary Outcomes (1)

• RP Attacks Per Day

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

  baselin and 4 weeks

Secondary Outcomes (8)

• Change in Raynaud's Condition Score (RCS)

  baseline and 4 weeks

• Change in the RP Duration

  baseline and 4 weeks

• Change in Health Assessment Questionnaire (HAQ)

  0 and 4 weeks

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

  at 0 (baseline) and 4 weeks (after treatment)

• Change in Digital Ulcer Number

  baseline and 4 weeks

Study Arms (2)

Amlodipine-Udenafil (AU) arm

EXPERIMENTAL

Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks

Drug: Udenafil or Amlodipine

Udenafil-Amlodipine (UA) arm

EXPERIMENTAL

Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks

Drug: Udenafil or Amlodipine

Interventions

Udenafil or Amlodipine DRUG

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

Amlodipine-Udenafil (AU) arm; Udenafil-Amlodipine (UA) arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• secondary Raynaud's phenomenon

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Dong-A Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24352340 DERIVED

MeSH Terms

Conditions

Raynaud Disease; Signs and Symptoms

Interventions

udenafil; Amlodipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Eun Bong Lee
• Organization: Seoul National University

leb7616@snu.ac.kr

+82 2 2072-3944

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Direct, Division of Rheumatology

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 11, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-12

Locations

KR (1)