Raynaud´s disease (RD) is defined as episodic, painful, cold- or emotional stress-triggered vasospasms of the digital arteries and precapillary arterioles for up to 30 minutes with or without underlying disease, leading to ischemia of the fingers
Conditions
Interventions
Trade Name: Levitra 10 mg Filmtabletten
Product Name: Vardenafil
Product Code: Bay 38-9456
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vardenafil
CAS Number: 224785-91-5
Current Spons
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of Raynaud´s Disease (primary and secondary) for > 1 year - Age between 18 and 65 years - documented written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Previous or Current Medical Conditions Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the patient's ability to complete the study or precludes the patient’s participation in the study. Known contraindications for PDE-5 inhibitors (e.g. hypersensitivity, nitrate therapy, relevant CYP3A4-inhibitors, etc.) Necrosis of the finger tips Retinitis pigmentosa. History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C. Unstable angina pectoris. Severe congestive heart failure (NYHA stages III or IV). History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to Visit 1. Uncontrolled atrial fibrillation/flutter at Visit 1 (ventricular response rate > 100 beats per minute). Prolonged QTc-time (> 450 msec) Congenital Long-QT-Syndrom Hypopotassemia Severe chronic or acute liver disease. Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia and leukemia. Bleeding disorder. Significant active peptic ulceration. Resting hypotension (a resting systolic blood pressure of 170 mm Hg or a resting diastolic blood pressure >110 mm Hg). History of malignancy within the past 5 years (other than squamous or basal cell skin cancer). Patients with spinal lessions or known CNS-diseases Patients known to have or have had severe renal impairment (creatinine clearance 3 mg/dl at visit 1. Elevation of GOT / GPT to > 3 x upper limit Uncontrolled Diabetes mellitus (HbA1c > 9%) d. Other exclusion criteria Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra or other therapy for erectile dysfunction for the entire course of the study. History within the last 6 months of severe migraine headaches occurring once monthly or more frequently (a patient with a history of migraine headaches that are now well controlled on medication is acceptable for enrollment). Known hypersensitivity to any component of the investigational medication. Patients who are illiterate or are unable to understand the language in which the questionnaires or patient diary are available. Subjects unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with study medication. Pregnancy or breast feeding (pregancy test before enrollment). Female patients, in who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objectives of the study are to evaluate the efficacy of vardenafil in comparison to placebo on (i) the digital perfusion (laser flux Doppler) and (ii) the clinical symptoms (Raynaud Condition Score) of patients suffering from Raynaud´s disease. ;Secondary Objective: Adverse Events.;Primary end point(s): Peripheral perfusion as measured by Laser-Flux-Doppler Sonography at room temperature and cold exposure; Clinical outcome (Raynaud Condition Score) | — |
Countries
Germany
Outcome results
None listed