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

NCT ID: NCT01280266

Last Updated: 2012-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Raynaud Phenomenon

Keywords

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Pathological Conditions Signs and Symptoms Blood circulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Amlodipine-Udenafil (AU) arm

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

Group Type EXPERIMENTAL

Udenafil or Amlodipine

Intervention Type DRUG

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

Udenafil-Amlodipine (UA) arm

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

Group Type EXPERIMENTAL

Udenafil or Amlodipine

Intervention Type DRUG

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

Interventions

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Udenafil or Amlodipine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun Bong Lee

Direct, Division of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Bong Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

professor of Seoul National University College of Medicine

Eun Young Lee, MD PhD

Role: STUDY_DIRECTOR

Assistant professor, Seoul National University College of Medicine

Jin Kyun Park, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24352340 (View on PubMed)

Other Identifiers

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RaynaudSNUH

Identifier Type: -

Identifier Source: org_study_id