EUCTR2005-000295-41-DE进行中（未招募）1 期
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.
niversität zu Köln0 个研究点目标入组 57 人开始时间: 2005年12月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •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
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