NCT01291199已完成2 期
Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With Raynaud's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change in the Raynaud's Condition Score
研究概览
简要总结
The purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •raynaud-syndrome (primary or secondary) > 1 year duration
- •age ≥ 18 years; ≤ 80 years
- •informed consent
- •a negative pregnancy test in women of child-bearing age
排除标准
- •any unstable organic, psychiatric or addictive disease, which - in the opinion of the investigators - might result in an unsuccessful / unreliable participation or premature termination of the trial
- •known contraindications against PDE 5-inhibitors (such as intolerance, therapy with nitrates or inhibitors of CYP3A4, etc.)
- •extensive necrosis of the finger tips
- •pigmentary retinopathy
- •verification as a HbsAg or hepatitis C carrier
- •unstable angina
- •heart failure (NYHA III or IV)
- •valve defects of higher degree (particularly aortic stenosis and hypertrophic obstructive cardiomyopathy)
- •myocardial infarction, stroke or life-threatening cardiac arrhythmias within the last 6 months
- •uncontrolled atrial fibrillation / -flutter with a heart rate > 100 bpm
- •prolonged QTc-interval (> 450 msec)
- •congenital long-QT-syndrome
- •hypokalemia
- •severe acute or chronic liver disease, which might lead to priapism (sickle cell anemia, leucemia)
- •hemophilia
- •active peptic ulcers
- •arterial hypotension (systolic blood pressure at rest <90 mmHg) or
- •arterial hypertension(systolic blood pressure at rest >170 mmHg or diastolic blood pressure at rest >110 mmHg)
- •malignancy within the last 5 years (except squamous or basal cell skin cancer)
- •patients with injuries of the spinal cord or central nervous system
- •patients with severe chronic kidney disease (creatinin clearance < 30 ml)
- •patients with mild to severe liver disease (Child-Pugh A-C)
- •Age below 18 or above 80
- •prohibited concomitant medication during the study:
- •nitrates or other NO-donators (including amylnitrit)
- •anticoagulative drugs except inhibitors of thrombocyte function
- •androgens (such as testosterone) or anti-androgens
- •strong inhibitors of cytochrome P4503A4:
- •very potent HIV-Protease-inhibitors (ritonavir, indinavir)
- •anti-mycotic like itraconazole and ketoconazole (topical applications are allowed)
- •erythromycin
- •grapefruit-juice or products containing grapefruit-juice
- •other study medications (including placebo) up to 30 days before study inclusion
- •therapy of erectile dysfunction(including sildenafil, sublingual apomorphin, MUSE®, intracavernous injections or vacuum pumps) or other therapies of erectile dysfunction within 4 weeks and during the trial period
- •nebivolol
- •alpha-blockers
- •Calcium antagonists
- •medications prolonging the QT-interval
- •abnormal lab tests like:
- •serum-creatinine > 3 mg/dl at visit 1
- •GOT and GPT > 3 x reference limit set
- •diabetes mellitus with a HbA1c > 9%
- •patients who are not willing to disclaim a therapy of their erectile dysfunction with vacuum pumps, intravenous injections, sildenafil or other therapies during the trial
- •severe migraine (more than once a moth during the last 6 months)
- •intolerance to the study medication
- •patients who are not able to understand the information and informed consent due to a mental disorder or linguistic barriers
- •persons who are living in a institution directly under federal government control due to a court order
- •patients who refuse to renounce drinking grapefruit juice during the trial
- •women who are pregnant or lactating
- •women who are not protected from a pregnancy (intake of oral contraceptives alone in insufficient; highly effective methods of birth control have to be used with a failure rate <1%; barriers: implants, intrauterine-devices (IUD´s),diaphragm, condoms, abstinence, partner is vasectomized, spermicides)
- 另有 1 项未显示
研究组 & 干预措施
Vardenafil 10 mg bid
Experimental
干预措施: vardenafil (Drug)
Vardenafil 10 mg bid
Experimental
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: vardenafil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Raynaud's Condition Score
时间窗: daily for 18 weeks
The Raynaud's Condition Score (RCS) is a clinically validated scale used to determine the difficulty that patients experience with Raynaud's phenomenon, and is closely associated with the measures of disability and overall impact and activity of the disease.
次要结局
- Number of participants with adverse events as a Measure of Safety and Tolerability(daily for 18 weeks)
- Digital blood flow(at baseline, one hour after drug intake and after six weeks on therapy)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile DysfunctionErectile DysfunctionNCT00658177Bayer463
已完成
3 期
Study Evaluating the Efficacy, Safety, and Reliability of VardenafilErectile DysfunctionNCT00661297Bayer523
已完成
2 期
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder FunctionDetrusor OveractivityOveractive BladderNCT00478881Bayer397
已完成
4 期
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic SyndromeMetabolic SyndromeErectile DysfunctionNCT00738400Bayer150
已完成
2 期
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile DysfunctionErectile DysfunctionNCT00656188Bayer463