Double-blind,placebo-controlled cross-over study for evaluation of the efficacy of the PDE-5-inhibitor vardenafil on the peripheral perfusion and the clinical symptomatology of patients with Raynaud´s disease.

Phase 1

• Conditions: 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

• Registration Number: EUCTR2005-000295-41-DE
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2010-04-07
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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

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 <90 mm Hg) or hypertension (a resting systolic blood pressure >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 < 30 ml).
Patients known to suffer from mild to severe hepatic impairment (Child-Pugh A-C).
Patients under 18 or above 80 years of age

b. Concomitant Medication
All drugs that are taken in addition to the study drug during the course of the study are considered as concomitant medication. The use of any concomitant medication must be documented. The following concomitant medications are NOT allowed:
Nitrates or nitric oxide donors.
Androgens (e.g. testosterone).
Anti-androgens.
Anticoagulants, except for antiplatelet agents.
Patients who are taking the following inhibitors of cytochrome P 450 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical preparations are allowed) or erythromycin.
Patients who have received any investigational drug (including placebo) within 30 days of Visit 1.
Subjects who are taking nebivolol
Subjects who are taking alpha-blockers
Subjects who are taking Calcium-Chanel-Blockers

c. Abnormal Laboratory Values
Serum creatinine > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)