Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome

University of Cologne

Status and phase

Completed

Phase 3

Phase 2

Conditions

Raynaud Syndrome

Treatments

Drug: vardenafil

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01291199

Ro-002/05

2005-000295-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
patients who participated in other interventional studies within 30 days of study inclusion